UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
 
FORM 10-Q/A (Amendment No. 1)10-Q
(Mark One)
 
þQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the quarterly period ended June 30, 2018
March 31, 2019
¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the transition period from ______________________ to_______________________
 
Commission File Number 001-08568
 
Teligent, Inc.
(Formerly IGI Laboratories, Inc.)
(Exact name of registrant as specified in its charter)
Delaware01-0355758
(State or other Jurisdiction of(I.R.S. Employer Identification No.)
incorporation or organization)
Delaware01-0355758
(State or other Jurisdiction of(I.R.S. Employer Identification No.)
incorporation or organization)
105 Lincoln Avenue
Buena, New Jersey08310
(Address of Principal Executive Offices)(Zip Code)
 
(856) 697-1441
(Registrant's telephone number, including area code)
 
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes þ     No ¨
 
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes þ     No ¨
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company or an emerging growth company. See the definitions of "large“large accelerated filer," "accelerated” “accelerated filer,"” “smaller reporting company” and "smaller reporting company"“emerging growth company” in Rule 12b-2 of the Exchange Act.
 
Large accelerated filer¨Accelerated filerþ
Non-accelerated filer¨Smaller reporting companyþ
Emerging growth company¨
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). ☐




1

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐


Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨     No þ


The number of shares outstanding of the issuer's common stock is 53,537,88853,850,427 shares as of AugustMay 6, 2018.2019.














2

OTHER INFORMATION
 
When used in this report, the terms, “we,” the “Company,” “our,” and “us” refer to Teligent, Inc., a Delaware corporation (formerly IGI Laboratories, Inc.), and its consolidated subsidiaries.


EXPLANATORY NOTE
3


We are filing this Amendment No. 1 on Form 10-Q/A (the "Form 10-Q/A") to revise and restate the following items of our Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, which we originally filed with the Securities and Exchange Commission on August 9, 2018 (the “Original Form 10-Q”):

(i)Item 1 of Part I “Financial Information”
(ii)Item 2 of Part II “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
(iii)Item 4 of Part II "Controls and Procedures"
(iv)Item 6 of Part II “Exhibits”

We have also updated the signature page, the certifications of our Chief Executive Officer and Chief Financial Officer in Exhibits 31.1, 31.2, 32.1, and 32.2 and our financial statements formatted in Extensible Business Reporting Language (XBRL). No other sections were affected by the restatement, but for the convenience of the reader, this report on Form 10-Q/A restates in its entirety, as amended, our Original Form 10-Q.

On November 8, 2018, after discussions with the Company’s Audit Committee, management concluded that the unaudited interim condensed consolidated financial statements included in the Original Form 10-Q for the quarter ended June 30, 2018 were required to restate to correct the following accounting errors:

1.To correct the accounting for the early and partial extinguishment of the Company’s Convertible 3.75% Senior Notes due 2019 (the “2019 Notes”) that resulted from the separate exchange agreements entered into with certain holders of the 2019 Notes in April 2018.
2.To correct certain other accounting errors which management believes are immaterial on an individual and aggregate basis to the Company’s unaudited interim condensed consolidated financial statements.

Note 1, Restatement of Previously Issued Unaudited Interim Condensed Consolidated Financial Statements, in the Company’s unaudited interim condensed consolidated financial statements included in Item 1 of Part I “Financial Information” provides further information regarding the correction of these accounting errors. In addition, Item 4 “Controls and Procedures” of Part I “Financial Information” discloses the material weaknesses in the Company’s internal control over financial reporting associated with the correction of these accounting errors.  As disclosed therein, management is currently evaluating the changes needed in the Company’s internal control over financial reporting to remediate these material weaknesses.

This report on Form 10-Q/A has been signed as of a current date and all certifications of the Company’s Chief Executive Officer and Chief Financial Officer are given as of a current date. Except as discussed above, the Company has not modified, or updated disclosures presented in this Form 10-Q/A. Accordingly, the Form 10-Q/A does not reflect events occurring after the Original Form 10-Q or modify or update those disclosures affected by subsequent events, except as specifically referenced herein. Information not affected by the correction of the foregoing accounting errors is unchanged and reflects the disclosures made at the time of the Original Form 10-Q.




PART I
FINANCIAL INFORMATION

ITEM 1. Financial Statements









TELIGENT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS


(in thousands, except share and per share information)
(Unaudited)
 June 30, 2018 (As Restated - See Note 1) December 31, 2017
March 31, 2019
(unaudited)		December 31, 2018
ASSETS  
  
ASSETS
Current assets:  
  
Current assets:
Cash and cash equivalents $13,675
 $26,692
Cash and cash equivalents$6,397 $9,705 
Accounts receivable, net 16,081
 12,742
Inventories, net 17,575
 16,075
Restricted cashRestricted cash206 2,892 
Accounts receivable, net of allowance for doubtful accounts of $2,531 and $2,636, as of March 31, 2019 and December 31, 2018, respectivelyAccounts receivable, net of allowance for doubtful accounts of $2,531 and $2,636, as of March 31, 2019 and December 31, 2018, respectively15,412 16,120 
InventoriesInventories20,954 16,296 
Prepaid expenses and other receivables 2,206
 3,622
Prepaid expenses and other receivables2,806 3,373 
Total current assets 49,537
 59,131
Total current assets45,775 48,386 
    
Property, plant and equipment, net 83,290
 68,355
Property, plant and equipment, net94,392 91,775 
Intangible assets, net 52,930
 56,017
Intangible assets, net46,818 48,375 
Goodwill 445
 471
Goodwill480 470 
Other assets 577
 611
Other assets4,397 1,886 
Total assets $186,779
 $184,585
Total assets$191,862 $190,892 
    
LIABILITIES AND STOCKHOLDERS’ EQUITY  
  
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:  
  
Current liabilities:
Accounts payable $8,771
 $10,595
Accounts payable$7,555 $5,933 
Accrued expenses 9,269
 8,101
Accrued expenses9,303 9,842 
Deferred incomeDeferred income1,875 2,426 
Convertible 3.75% Senior Notes, net of debt discount and debt issuance costs (face of $13,022 and $15,702 as of March 31, 2019 and December 31, 2018, respectively)Convertible 3.75% Senior Notes, net of debt discount and debt issuance costs (face of $13,022 and $15,702 as of March 31, 2019 and December 31, 2018, respectively)12,214 14,411 
Other current liabilitiesOther current liabilities407 — 
Total current liabilities 18,040
 18,696
Total current liabilities31,354 32,612 
    
2021 Term Loan, net of debt discount and debt issuance costs (face of $15,000 as of June 30, 2018) 14,198
 —
Convertible 3.75% Senior Notes, net of debt discount and debt issuance costs (face of $68,660 and $143,750 as of June 30, 2018 and December 31, 2017, respectively) 60,312
 120,977
Convertible 4.75% Senior Notes, net of debt discount and debt issuance costs (face of $75,090 as of June 30, 2018)
 55,369
 —
Convertible 4.75% Senior Notes, net of debt discount and debt issuance costs (face of $75,090 as of March 31, 2019 and December 31, 2018, respectively)Convertible 4.75% Senior Notes, net of debt discount and debt issuance costs (face of $75,090 as of March 31, 2019 and December 31, 2018, respectively)57,723 56,909 
Revolver, net of debt issuance costs (face of $20,000 and $15,000 as of March 31, 2019 and December 31, 2018, respectively)Revolver, net of debt issuance costs (face of $20,000 and $15,000 as of March 31, 2019 and December 31, 2018, respectively)20,000 15,000 
2023 Term Loan, net of debt issuance costs (face of $72,020 and $70,000 as of March 31, 2019 and December 31, 2018, respectively)2023 Term Loan, net of debt issuance costs (face of $72,020 and $70,000 as of March 31, 2019 and December 31, 2018, respectively)69,766 67,662 
Deferred tax liability 148
 159
Deferred tax liability220 215 
Other long term liabilitiesOther long term liabilities2,579 73 
Total liabilities 148,067
 139,832
Total liabilities181,642 172,471 
    
Commitments and Contingencies 

 

Commitments and Contingencies
    
Stockholders’ equity:  
  
Stockholders’ equity:
Common stock, $0.01 par value, 100,000,000 shares authorized; 53,512,888 and 53,400,281 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively 554
 554
Common stock, $0.01 par value, 100,000,000 shares authorized; 53,845,427 and 53,774,221 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectivelyCommon stock, $0.01 par value, 100,000,000 shares authorized; 53,845,427 and 53,774,221 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively558 557 
Additional paid-in capital 118,524
 106,312
Additional paid-in capital117,239 116,864 
Accumulated deficit (78,015) (60,094)Accumulated deficit(105,074)(96,350)
Accumulated other comprehensive loss (2,351) (2,019)Accumulated other comprehensive loss(2,503)(2,650)
Total stockholders’ equity 38,712
 44,753
Total stockholders’ equity10,220 18,421 
Total liabilities and stockholders' equity $186,779
 $184,585
Total liabilities and stockholders' equity$191,862 $190,892 
 
The accompanying notes are an integral part of the condensed consolidated financial statements.



4

TELIGENT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except shares and per share information)
(Unaudited)
 
Three months ended March 31,
20192018
Revenue, net$13,122 $14,545 
Costs and expenses:
Cost of revenues7,360 9,325 
Selling, general and administrative expenses5,513 5,360 
Product development and research expenses2,989 3,391 
Total costs and expenses15,862 18,076 
Operating loss(2,740)(3,531)
Other (Expense) Income:
Foreign currency exchange (loss) gain(844)1,325 
Debt partial extinguishment of 2019 Notes(185)— 
Interest and other expense, net(4,947)(2,572)
Loss before income tax expense(8,716)(4,778)
Income tax expense8 24 
Net loss attributable to common shareholders$(8,724)$(4,802)
Basic and diluted loss per share$(0.16)$(0.09)
Weighted average shares of common stock outstanding:
Basic and diluted shares53,805,983 53,458,513 
  Three months ended June 30, Six months ended June 30,
  2018 2017 2018 2017
  (As Restated - See Note 1)   (As Restated - See Note 1)  
   
  
    
Revenue, net 16,249
 16,432
 30,794
 34,095
         
Costs and expenses:  
  
  
  
Cost of revenues 11,465
 8,395
 20,790
 15,124
Selling, general and administrative expenses 5,727
 4,706
 11,087
 9,005
Product development and research expenses 3,967
 5,113
 7,358
 8,781
Total costs and expenses 21,159
 18,214
 39,235
 32,910
Operating (loss) income (4,910) (1,782) (8,441) 1,185
         
Other income (expense):  
  
  
  
Foreign currency exchange (loss) gain (3,220) 3,822
 (1,895) 4,901
Debt partial extinguishment of Convertible 3.75% Senior Notes (2,467) —
 (2,467) —
Interest and other expense, net (2,499) (2,936) (5,071) (6,068)
(Loss) income before income tax expense (13,096) (896) (17,874) 18
         
Income tax expense 23
 23
 47
 106
         
Net loss attributable to common shareholders $(13,119) $(919) $(17,921) $(88)
         
Basic and diluted loss per share $(0.25) $(0.02) $(0.34) $—
         
Weighted average shares of common stock outstanding:  
  
  
  
Basic and diluted shares 53,510,712
 53,304,407
 53,484,756
 53,250,109



 The accompanying notes are an integral part of the condensed consolidated financial statements.



5

TELIGENT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)LOSS
(in thousands)
(Unaudited)
 
Three months ended March 31,
20192018
Net loss$(8,724)$(4,802)
Other comprehensive income (loss), net of tax:
Foreign currency translation adjustment147 (304)
Other comprehensive income (loss)147 (304)
Comprehensive loss$(8,577)$(5,106)
  Three months ended June 30, Six months ended June 30
  2018 2017 2018 2017
  (As Restated - See Note 1)   (As Restated - See Note 1)  
Net loss $(13,119) $(919) $(17,921) $(88)
         
Other comprehensive loss, net of tax;    
  
  
Foreign currency translation adjustment (28) (163) (332) (245)
Other comprehensive loss (28) (163) (332) (245)
         
Comprehensive loss $(13,147) $(1,082) $(18,253) $(333)


The accompanying notes are an integral part of the condensed consolidated financial statements.


6

TELIGENT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY
(in thousands, except share information)
(Unaudited)
(As Restated - See Note 1)
 
AdditionalAccumulated
Other		Total
Common StockPaid-InAccumulatedComprehensiveStockholders’
SharesAmountCapitalDeficitLossEquity
Balance, December 31, 2018 (audited)53,774,221 $557 $116,864 $(96,350)$(2,650)$18,421 
Stock based compensation expense— — 376 — — 376 
Issuance of stock for vested restricted stock units71,206 1 (1)— — — 
Cumulative translation adjustment— — — — 147 147 
Net loss— — — (8,724)— (8,724)
Balance, March 31, 2019 (unaudited)53,845,427 $558 $117,239 (105,074)$(2,503)$10,220 
      Additional Accumulated
Other		   Total
  Common Stock Paid-In Comprehensive Accumulated Stockholders’
  Shares Amount Capital Loss Deficit Equity
Balance, December 31, 2017 53,400,281
 $554
 $106,312
 $(2,019) $(60,094) $44,753
             
Stock based compensation expense —
 —
 1,165
 —
 —
 1,165
Stock options exercised 11,000
 —
 12
 —
 —
 12
Issuance of stock for vested restricted stock units 101,607
 —
 —
 —
 —
 —
Fair value of conversion feature on Convertible 4.75% Senior Notes —
 —
 18,637
 —
 —
 18,637
Partial extinguishment of equity component of Convertible 3.75% Senior Notes —
 —
 (7,602) —
 —
 (7,602)
Cumulative translation adjustment —
 —
 —
 (332) —
 (332)
Net loss —
 —
 —
 —
 (17,921) (17,921)
             
Balance, June 30, 2018 53,512,888
 $554
 $118,524
 $(2,351) $(78,015) $38,712


The accompanying notes are an integral part of the condensed consolidated financial statements.


7

TELIGENT, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(Unaudited)
 Six months ended June 30,
 2018 2017Three months ended March 31,
 (As Restated - See Note 1)  20192018
Cash flows from operating activities:  
  
Cash flows from operating activities:
Net loss $(17,921) $(88)Net loss$(8,724)$(4,802)
Reconciliation of net loss to net cash used in operating activities  
  
Depreciation and amortization of fixed assets 1,133
 822
Provision for bad debt expense 811
 26
Reconciliation of net loss to net cash (used in) provided by operating activities:Reconciliation of net loss to net cash (used in) provided by operating activities:
Depreciation of fixed assets and leasesDepreciation of fixed assets and leases876 561 
Provision for bad debtProvision for bad debt(105)— 
Provision for write down of inventory 1,154
 918
Provision for write down of inventory453 602 
Stock based compensation 1,103
 1,739
Stock based compensation368 616 
Amortization of debt issuance costs 505
 456
Amortization of debt costs and debt discountAmortization of debt costs and debt discount1,523 2,594 
Amortization of intangible assets 1,550
 1,396
Amortization of intangible assets756 791 
Non cash lease expenseNon cash lease expense97 — 
Foreign currency exchange loss (gain) 1,895
 (4,901)Foreign currency exchange loss (gain)844 (1,325)
Partial extinguishment of Convertible 3.75% Senior Notes 2,467
 —
Partial extinguishment of Convertible 3.75% Senior Notes185 — 
Amortization of debt discount 4,422
 4,183
Loss on impairment of intangible assets 22
 —
Loss on impairment of intangible assets— 22 
Changes in operating assets and liabilities    
Non cash interest expenseNon cash interest expense2,020 — 
Changes in operating assets and liabilities:Changes in operating assets and liabilities:
Accounts receivable (4,227) (4,008)Accounts receivable892 (711)
Inventories (2,816) (2,554)Inventories(5,063)(2,376)
Prepaid expenses and other current receivables 1,443
 (208)
Other assets 35
 20
Prepaid expenses, other current receivables and assetsPrepaid expenses, other current receivables and assets558 902 
Accounts payable and accrued expenses (4,086) 892
Accounts payable and accrued expenses(95)(6,423)
    
Operating liabilitiesOperating liabilities(85)— 
Deferred incomeDeferred income(551)— 
Net cash used in operating activities (12,510) (1,307)Net cash used in operating activities(6,051)(9,549)
    
Cash flows from investing activities:  
  
Cash flows from investing activities:
Capital expenditures (12,523) (15,286)Capital expenditures(2,129)(4,094)
    
Net cash used in investing activities (12,523) (15,286)Net cash used in investing activities(2,129)(4,094)
Cash flows from financing activities:Cash flows from financing activities:
    
Cash flows from financing activities:  
  
Proceeds from exercise of common stock options 12
 267
Proceeds from 2021 Term Loan 15,000
 —
Debt fees on Convertible 4.75% Senior Notes and 2021 Term Loan (2,457) —
    
Proceeds from RevolverProceeds from Revolver5,000 — 
Debt issuance costsDebt issuance costs(109)— 
Repurchase of 3.75% senior notesRepurchase of 3.75% senior notes(2,686)— 
Principal paid on lease obligationPrincipal paid on lease obligation(3)— 
Net cash provided by financing activities 12,555
 267
Net cash provided by financing activities2,202 — 
    
Effect of exchange rate on cash and cash equivalents (540) 536
Effect of exchange rate on cash and cash equivalents(16)(287)
Net decrease in cash, cash equivalents and restricted cash (12,478) (16,326)Net decrease in cash, cash equivalents and restricted cash(5,978)(13,643)
Cash, cash equivalents and restricted cash at beginning of period 27,165
 66,481
Cash, cash equivalents and restricted cash at beginning of period13,069 27,165 
    
Cash, cash equivalents and restricted cash at end of period $14,147
 $50,691
Cash, cash equivalents and restricted cash at end of period$7,075 $13,235 
    
Supplemental Cash flow information:  
  
Supplemental Cash flow information:
Cash payments for interest $2,475
 $2,695
Cash payments for interest$278 $— 
Cash payments for income taxes 48
 93
Cash payments for income taxes20 15 
Non-cash operating, investing and financing transactions:Non-cash operating, investing and financing transactions:
    
Non cash operating, investing and financing transactions:  
  
Acquisition of capital expenditures in accounts payable and accrued expenses $3,042
 $4,260
Acquisition of capital expenditures in accounts payable and accrued expenses1,365 3,421 
Capitalized interest in capital expenditures 477
 —
Capitalized interest in capital expenditures— 1,348 
Capitalized stock compensation in capital expenditures 63
 66
Capitalized stock compensation in capital expenditures10 30 
The accompanying notes are an integral part of the condensed consolidated financial statements.


8

TELIGENT, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10-018-03 of Regulation S-XS-X. Accordingly, they do not include all of the information and footnotes required by GAAP . In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017,2018, as updated by other reports we may file from time to time with the Securities and Exchange Commission (“SEC”). The condensed consolidated balance sheet as of December 31, 20172018 has been derived from those audited consolidated financial statements. Operating results for the six-monththree month period ended June 30, 2018March 31, 2019 are not necessarily indicative of the results that may be expected for the year ending December 31, 2018.2019.
 

9

1. RestatementCorrection of Previously Issued Unaudited Interim Condensed Consolidated Financial Statements


SubsequentAs previously disclosed in the Company’s 2018 Form 10-K, subsequent to the issuance of the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, management determined a material adjustment wasadjustments were needed to correct the presentation of certain immaterial accounting for the early and partial extinguishment oferrors in the Company’s Convertible 3.75% Senior Notes due 2019 (the “2019 Notes”) that resulted from the separate exchange agreements entered into with certain holders of the 2019 Notes in April 2018 (see Note 7 for further information regarding the 2019 Notes). Accordingly, the accompanying unaudited interim condensed consolidated financial statements of the Company for the three and six-months ended June 30, 2018, and the related notes hereto, have been restated to correct this error. In addition, the Company has elected to correct certain other accounting errors, which management believes are immaterial on an individual and aggregate basis to the Company’s unaudited interim condensedpreviously reported consolidated financial statements for the threeyears ended December 31, 2017 and six-months ended June 30, 2018 and 2017. The correction of all the foregoing accounting errors is collectively referred to herein as "the Restatement". A summary of the correction of these accounting errors, and their impact on the unaudited condensed consolidated financial statements for the three and six-month periods ended June 30, 2018 and June 30, 2017, are as follows:

(1)In April 2018, the Company entered into separate exchange agreements with certain holders of the 2019 Notes to exchange an aggregate of $75.1 million of the 2019 Notes for an equal amount of newly issued Convertible 4.75% Senior Notes due 2023. The effect of this exchange was accounted for as an early and partial extinguishment of $75.1 million of the 2019 Notes, whereby an aggregate of approximately $10.1 million unamortized debt discount and financing costs associated with the 2019 Notes were written off and recognized as non-cash interest expense. Upon further analysis, management determined that the exchange of $75.1 million of 2019 Notes should have been accounted for by applying the cash conversion guidance prescribed by ASC 470-20, which requires, upon derecognition, among other things, an allocation of the fair value of the consideration transferred at settlement between (i) the extinguished liability component and (ii) the reacquired equity component.2016. Accordingly, the accompanying unaudited interim condensed consolidated financial statements as of and for the threeyears ended December 31, 2017 and six-month periods ended June 30, 2018 have been restated to reflect2016, and the application of this guidance in ASC 470-20 by decreasing the amount of non-cash interest expense recognized during the three and six-month periods ended June 30, 2018 by approximately $7.6 million, increasingrelated notes (including the Company’s outstanding Convertible 4.75% Senior Notes, netquarterly results disclosed in Note 15, Quarterly Results), were revised to correct these immaterial accounting errors (the “Revision”) in the Company’s 2018 Form 10-K. A summary of debt discountthese immaterial accounting errors, and debt issuance costs, as of June 30, 2018 by approximately $0.4 million, and decreasing additional paid-in capital as of June 30, 2018 by approximately $8.0 million.

(2)The Company identified approximately $0.3 million of uncollectible accounts receivable related to certain prior period pricing and shipment errors. Accordingly,their impact on the accompanying unaudited interim condensed consolidated financial statements asstatement of andcash flows for the three and six-month periodsmonths ended June 30,March 31, 2018 has been revised to reflect the write-off of these out of period amounts by decreasing Revenue, net by approximately $0.3 million for the three and six-month periods ended June 30, 2018, respectively, decreasing Accounts Receivable, net, by $0.4 million and increasing Accounts Payable by $0.1 millionare, as of June 30, 2018.follows:


(3)The Company identified approximately $0.2 million of uncollectible accounts receivable related to pricing and shipment errors that were previously written off and incorrectly classified within as Selling, General and Administrative Expenses rather than a reduction of Revenue, net. Accordingly, the accompanying unaudited interim condensed consolidated financial statements as of and for the three and six-month periods ended June 30, 2018 has been revised to reflect the proper classification of this amount by decreasing Revenues, net and decreasing Selling, General and Administrative Expenses by approximately $0.2 million for the three and six-month periods ended June 30, 2018, respectively.

(4)The Company identified approximately $0.3 million of costs that were previously incurred and should have been


capitalized to Property, Plant and Equipment, net rather than recognized as Cost of Revenues. Accordingly, the accompanying unaudited interim condensed consolidated financial statements as of and for the three and six-month periods ended June 30, 2018 has been revised to reflect the proper classification of this out of period amount by increasing Property, Plant, and Equipment as of June 30, 2018 and reducing Cost of Revenues for the three and six-month periods ended June 30, 2018 by approximately $0.3 million, respectively. The effect on depreciation expense associated with the correction of this error was nil.
(5)(1) The Company pays wholesalers certain fees associated with the sale of the Company’sCompany's product. The payment of these fees had been historically classified by the Company as cost of revenues and accrued expenses prior to the adoption of ASC 606, Revenue from Contracts with Customers. Customers ("ASC 606"). As disclosed in Note 4,7, Revenues, Recognition and Allowances, of the 2018 Form 10-K, the Company adopted ASC 606 on January 1, 2018 using the modified retrospective method, at which time the Company began classifying the payment of wholesaler fees as a reduction of revenue and accounts receivable. Upon further analysis, however, management determined that these fees should have always been classified as a reduction of revenue and accounts receivable, rather than as costs of revenues and accrued expenses, because the services provided by the Company’s wholesalers cannot generally be provided by third parties and the underlying fees are not specifically identifiable from other services. As a result, the accompanying unaudited interim condensed consolidated financial statements as of and for the three and six-month periods ended June 30, 2017 has been revised to correct the presentation of wholesaler fees as a reduction of revenue rather than as cost of revenues.

The correction of this error resulted in a reduction of revenue of approximately of $2.0 million and $4.2 million, respectively, for the three and six-month periods ended June 30, 2017. In addition, the correction of this error resulted in a reduction inpreviously reported accounts receivable and decrease in previously reported accrued expenses of approximately $5.4 million, respectively, as of June 30, 2017 and $7.0 million, respectively, as of December 31, 2017.


(6)(2) Prior to the adoption of ASC 606, the Company classified Medicaid, Medicare and other rebates (the “Rebates”"Rebates") as a reduction of accounts receivable, whereas subsequent to adoption of ASC 606 the Company began classifying the Rebates as accrued expenses. Upon further analysis, management determined that the Rebates should have always been classified as accrued expenses because their terms require cash settlement and are payable to third parties that are other than the Company’sCompany's customer. The correction of this immaterial error resulted in an increase in previously reported accounts receivable and increase in previously reported accrued expenses of $2.5 million, respectively, as of June 30, 2017 and $1.6 million, respectively, as of December 31, 2017.


The following tables summarize the effecteffects of the RestatementRevision on the Company's unaudited interim condensedaccompanying consolidated financial statements asstatement of andcash flows of the Company for the three and six-monthsmonths ended June 30, 2017 (in thousands):March 31, 2018:



Consolidated Statement of Cash Flows
Three Months Ended March 31, 2018
As Previously ReportedAdjustmentAs Revised
Cash flows from operating activities
Accounts receivable$4,690 $(5,401)(1)(2) $(711)
Accounts payable and accrued expenses(11,824)5,401 (1)(2) (6,423)


10
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
            
 Three months ended June 30, 2018 Six months ended June 30, 2018
 As Previously Reported Adjustments As Restated As Previously Reported Adjustments As Restated
Revenues:           
Revenues, net$16,751
 $(502)(2), (3)$16,249
 $31,296
 $(502)(2), (3)$30,794
            
Costs and Expenses:           
Cost of revenues11,728
 (263)(4)11,465
 21,053
 (263)(4)20,790
Selling, general and administrative expenses5,961
 (234)(3)5,727
 11,321
 (234)(3)11,087
            
Total costs and expenses21,656
 (497) 21,159
 39,732
 (497) 39,235
            
Operating loss(4,905) (5) (4,910) (8,436) (5) (8,441)
            
Other Income (Expense):           
Partial extinguishment of Convertible 3.75% Notes(10,069) 7,602
(1)(2,467) (10,069) 7,602
(1)(2,467)
            
Loss before income tax expense(20,693) 7,597
 (13,096) (25,471) 7,597
 (17,874)
            
Net loss$(20,716) $7,597
 $(13,119) $(25,518) $7,597
 $(17,921)
            
Basic and diluted loss per share$(0.39) $0.14
 $(0.25) $(0.48) $0.14
 $(0.34)





CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
      
 June 30, 2018   June 30, 2018
As Previously Reported Adjustments As Restated
Accounts receivable, net$16,232
 $(151)(2)$16,081
Total current assets49,688
 (151) 49,537
      
Property, plant and equipment83,027
 263
(4)83,290
      
Total assets$186,667
 $112
 $186,779
      
Current liabilities:     
Accounts payable$8,654
 $117
(2)$8,771
      
Total current liabilities17,923
 117
 18,040
      
Convertible 4.75% Senior Notes, net of debt discount and debt issuance costs (face of $75,090, as of June 30, 2018)54,963
 406
(1)55,369
Total liabilities147,544
 523
 148,067
      
      
Additional paid in capital126,532
 (8,008)(1)118,524
Accumulated deficit(85,612) 7,597
 (78,015)
Total stockholders’ equity39,123
 (411) 38,712
Total liabilities and stockholders' equity$186,667
 $112
 $186,779


CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (Unaudited)
            
 Three months ended June 30, 2018 Six months ended June 30, 2018
 As Previously Reported Adjustments As Restated As Previously Reported Adjustments As Restated
Net loss$(20,716) $7,597
(1),(2),(3),(4)$(13,119) $(25,518) $7,597
(1),(2),(3),(4)$(17,921)
            
Comprehensive loss$(20,744) $7,597
(1),(2),(3),(4)$(13,147) $(25,850) $7,597
(1),(2),(3),(4)$(18,253)




CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (Unaudited)
      
 Six months ended June 30, 2018
 As Previously Reported Adjustments As Restated
Net loss$(25,518) $7,597
(1),(2),(3),(4)$(17,921)
Additional Paid in Capital126,532
 (8,008)(1)118,524
Total Stockholder's Equity$39,123
 $(411)(1),(2),(3),(4)$38,712


      
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
      
 Six months ended June 30, 2018
 As Previously Reported Adjustments As Restated
Cash flows from operating activities:     
Net income (loss)$(25,518) $7,597
(1),(2),(3),(4)$(17,921)
      
Stock based compensation1,113
 (10)(4)1,103
Partial extinguishment of Convertible 3.75% Senior Notes10,069
 (7,602)(1)2,467
      
Changes in operating assets and liabilities:     
Accounts receivable1,023
 (5,250)(2),(5), (a)(4,227)
Accounts payable and accrued expenses(9,604) 5,518
(5), (a)(4,086)
      
Net cash provided by operating activities(12,763) 253
 (12,510)
      
Cash flows from investing activities:     
Capital expenditures(12,270) (253)(4)(12,523)
      
Net cash used in investing activities(12,270) (253) (12,523)
      
Non cash investing and financing transactions:     
  Capitalized stock compensation in capital expenditures53 10
(4)63







 Condensed Consolidated Statements of Operations
 Three Months Ended June 30, 2017 Six Months Ended June 30, 2017
 As Previously Reported Adjustments As Revised As Previously Reported Adjustments As Revised
            
Revenue, net$18,408
 $1,976
(5)$16,432
 $38,299
 $4,204
(5)$34,095
Cost of revenues10,371
 1,976
(5)8,395
 19,328
 4,204
(5)15,124
Total costs and expenses20,190
 1,976
(5)18,214
 37,114
 4,204
(5)32,910

 Condensed Consolidated Balance Sheet Condensed Consolidated Balance Sheet
 June 30, 2017 December 31, 2017
 As Previously Reported Adjustments As Revised As Previously Reported Adjustments As Revised
            
Accounts receivable, net$27,272
 $2,853
(5),(6)$24,419
 $18,143
 $5,401
(5),(6)$12,742
     Total current assets95,009
 2,853
(5),(6)92,156
 64,532
 5,401
(5),(6)59,131
     Total assets196,385
 2,853
(5),(6)193,532
 189,986
 5,401
(5),(6)184,585
            
Accrued expenses12,019
 2,853
(5),(6)9,166
 13,502
 5,401
(5),(6)8,101
     Total current liabilities21,728
 2,853
(5),(6)18,875
 24,097
 5,401
(5),(6)18,696
     Total liabilities137,977
 2,853
(5),(6)135,124
 145,233
 5,401
(5),(6)139,832
Total liabilities and stockholders' equity196,385
 2,853
(5),(6)193,532
 189,986
 5,401
(5),(6)184,585

 Condensed Consolidated Statement of Cash Flows
 Six Months Ended June 30, 2017
 As Previously Reported Adjustments As Revised
      
Cash flows from operating activities     
     Accounts receivable$(5,530) $(1,522)(5),(6)$(4,008)
     Accounts payable and accrued expenses2,414
 1,522
(5),(6)892

2.  Nature of the Business and Liquidity


Nature of the Business


Teligent, Inc. and its subsidiaries (collectively the “Company”), is a specialty generic pharmaceutical company. Our mission is to become a leader in the specialty generic pharmaceutical market in alternate dosage forms. Under our own label, we currently market and sell generic topical and generic and branded generic injectable pharmaceutical products in the United States and Canada. In the United States, we currently market 2834 generic topical pharmaceutical products and four branded generic injectable pharmaceutical products. In Canada, we sell over 3027 generic and branded generic injectable products and medical devices. Generic pharmaceutical products are bioequivalent to their brand name counterparts. We also provide contract manufacturing services to the pharmaceutical, over-the-counter ("OTC"), and cosmetic markets. We operate our business under one reportable segment. Our common stock is traded on the NASDAQNasdaq Global Select Market under the


trading symbol “TLGT.”  Our principal executive office, laboratories and manufacturing facilities are located at 105 Lincoln Avenue, Buena, New Jersey. We have additional offices located in Iselin, New Jersey, Toronto,Mississauga, Canada, and Tallinn, Estonia.


Liquidity


Our capital resources were comprisedOn December 13, 2018, the Company and Ares Management LLC entered into: (i) a First Lien Revolving Credit Agreement, by and among the Company, as the borrower, certain subsidiaries of the Company, as guarantors, the lenders from time to time party thereto, and ACF Finco I LP, as administrative agent (the “Revolver Credit Agreement”) and (ii) a Second Lien Credit Agreement, by and among us, as the borrower, certain subsidiaries of ours, as guarantors, the lenders from time to time party thereto, and Ares Capital Corporation, as administrative agent (the “Second Lien Credit Agreement” and, together with the Revolver Credit Agreement, the “New Senior Credit Facilities”).

The New Senior Credit Facilities consist of (i) a $25.0 million senior revolving credit facility governed by the Revolver Credit Agreement (the “Revolver”); (ii) a $50.0 million second lien initial term loan (the “Initial Term Loan”); (iii) a $30.0 million second lien delayed draw term loan A (the “Delayed Draw Term Loan A”) and (iv) a $15.0 million second lien delayed draw term loan B (the “Delayed Draw Term Loan B” and the “Delayed Draw Term Loan A”, are hereto referred to as the “Delayed Draw Term Loans” and the Delayed Draw Term Loans together with the Initial Term Loan, hereto referred to as the “2023 Term Loans”). The Term Loans are governed by the Second Lien Credit Agreement. The Company's ability to borrow under the Revolver is subject to a “borrowing base” to be determined based upon eligible inventory, eligible equipment, eligible real estate and eligible receivables.

The Company’s principal sources of liquidity are cash and cash equivalents of $13.7approximately $6.4 million at March 31, 2019 and $26.7ongoing cash from operations. On March 31, 2019, the Company had access to an additional $5.0 million on its Revolver which was subsequently drawn down in April of 2019. The Company has an additional $25.0 million still available on its 2023 Term Loans, as part of June 30, 2018 and December 31, 2017, respectively. The reduction in our cash during the six months ended June 30, 2018 was largely duecredit facilities executed with Ares Capital Management, of which $15.0 million relates to our additional year-to-date investment of $12.5 millionfunding required to further increase manufacturing capacity in the Company's newnewly expanded Buena manufacturing facility locatedfacility.

The Company also has the ability to defer certain product development and other programs, as well as exercise its option to defer the payment of interest on its 2023 Term Loans, if necessary. As of March 31, 2019, the Company elected the paid-in-kind interest option and deferred interest expense of $2.0 million on its 2023 Term Loans.

However, the Company may require additional funding and this funding will depend, in Buena, New Jersey, along withpart, on the timing and structure of our accounts receivable collections and expense payments associated with our launch of five new products in the U.S. market. In addition, we had an accumulated deficit of $78.0 million as of June 30, 2018 and incurred a $17.9 million net loss and used $12.5 million in net cash from operating activities during the six months ended June 30, 2018.

Our liquidity needs have typically arisen from the funding of our manufacturing facility, research and development programs and the launch of new products. In the past, we have met these cash requirements through cash inflows from operations, working capital management, and proceeds from our Convertible 3.75% Senior Notes ("2019 Notes"). The 2019 Notes were issued in December 2014 and are due in December 2019. On April 27, 2018,potential business arrangements. If necessary, the Company entered into separate exchange agreements with certain holders of the 2019 Notes. The agreements gave the holder the right to exchange in aggregate $75.1 million of the 2019 Notes for $75.1 million of new Convertible 4.75% Senior Notes due 2023 (“2023 Notes”). Additional information is provided in Note 7. We expect tomay continue to incur significant expenditures for the development of new products in our pipeline, and the manufacturing and sales and marketing of our existing product. While we rely heavily on cash flows from operating activities and borrowings and from outside sourcesseek to execute our operational strategy and meet our financial commitments and other short-term financial needs, we cannot be certain that sufficient capital will be generated through operations or will be available to the Company to the extent required and on acceptable terms.

In order to continue normal business operations and execution of the Company’s growth strategy, the Company has and will continue to exercise its ability to significantly defer or reduce planned discretionary investments in research and development and capital projects or seek other financing alternatives. Other financing alternatives may include raisingraise additional capital through the sale of its equity or through a strategic alliance with a third party, or securing debt. Ifsubject to certain restrictions in the Ares Credit Facility agreements. There may also be additional acquisition and growth opportunities arise,that may require external financing will be required.

On May 4, 2018, the Company filed Form S-3 under the Securities Act of 1933. The S-3 registration allows the Company to issue, from time to time and at prices to be determined at or prior to the offering, up to $50.0 million of any combination of the securities described in the prospectus, either individually or in units should the need to raise cash arise.

On June 1, 2018, the Company secured a term loan ("2021 Term Loan") for $25.0 million to support the operations of the business. The first $15.0 million of loan proceeds was received on June 1, 2018. The remaining loan proceeds of $10.0 million was received on July 16, 2018. The Company is currently evaluating alternative financing methods. As the Company continues to review its capital and debt structure, therefinancing. There can be no assurance that a strategic alliance or debtsuch financing will be available on terms acceptable to the Company, or at all. The board of directors and management of the Company intend to exercise all options available in order to enable the Companybelieves that its existing capital resources will be sufficient to support its current growth strategybusiness plan and operations beyond December 2019.May 2020.


Out of Period Adjustments

For the three and six months ended June 30, 2018, the Company recorded the following adjustments (in thousands) related to prior periods. The net impact of the adjustments on any prior annual or interim periods financial statements was not significant. There were no adjustments related to prior periods recorded for the three and six months ended June 30, 2017.




11

Three months endedSix months ended

June 30, 2018June 30, 2018
Wholesale fees (Revenue)$856
$1,218
Medicaid (Revenue)297
297
Pricing and shipment adjustment (Revenue) (2), (3)(502)(502)
Sales return reserve (Revenue)—
(577)
Inventory adjustments (Cost of revenues)—
95
Capitalization of property, plant and equipment (Cost of revenues) (4)263
263
Bad debt expense (Selling, general and administrative expenses)(578)(578)

$336
$216


3. Summary of Significant Accounting Policies
 
Basis of Presentation 

The condensed consolidated financial statements contained in this report are unaudited. In the opinion of management, the condensed consolidated financial statements include all adjustments, which are of a normal recurring nature, necessary for a fair presentation of the results for the interim periods of the fiscal years ending December 31, 2019 and 2018. Certain information and disclosures normally included in consolidated financial statements prepared in accordance with GAAP have been condensed or omitted. Accordingly, the accompanying unaudited condensed consolidated financial statements should be read in conjunction with the notes to the audited consolidated financial statements contained in the Company’s Form 10-K for the year ended December 31, 2018, as filed with the Securities and Exchange Commission on April 1, 2019. 

Principles of Consolidation


The condensed consolidated financial statements include the accounts of Teligent, Inc. and its wholly-owned and majority-owned subsidiaries. All inter-company accounts and transactions have been eliminated. The Company consolidated the following entities: Igen, Inc., Teligent Pharma. Inc., Teligent Luxembourg S.à.r.l., Teligent OÜ, Teligent Canada Inc., and Teligent Jersey Limited., in addition to the following inactive entities: Microburst Energy, Inc., Blood Cells, Inc. and Flavorsome, Ltd.


Use of Estimates
 
The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. (GAAP)GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates include the historical valuation of the derivative liability, sales returns and allowances, allowances for excess and obsolete inventories, allowances for doubtful accounts, provisions for income taxes and related valuation allowances, stock based compensation, the assessment for the impairment of long-lived assets (including intangibles, goodwill and property, plant and equipment), property, plant and equipment and legal accruals for environmental cleanup and remediation costs. Actual results could differ from those estimates.


Cash Equivalents
 
The Company considers all highly liquid instruments purchased with the original maturity of three months or less to be cash equivalents to the extent the funds are not being held for investment purposes. Cash and cash equivalents include cash on hand and bank demand deposits used in the Company’s cash management program.


The Company has restricted cash, consisting of escrow accounts and letter of credits, which is included within other assets, non-current on the Company's Condensed Consolidated Balance Sheet.  TheIn addition, pursuant to the New Credit Facilities agreement, proceeds from the 2023 Term Loan are deposited in a blocked bank account and restricted for use with the exception of repurchasing remaining 2019 Notes.  In January and February of 2019, the Company also presentsused a total of $2.7 million of restricted cash with cash and cash equivalents into repurchase a portion of the Condensed Consolidated Statement of Cash Flows.remaining 2019 Notes (Note 8). 


The following table provides a reconciliation of cash and cash equivalents and restricted cash reported in the Condensed Consolidated Balance Sheet to the total amounts in the Condensed Consolidated Statement of Cash Flows as follows (in thousands):follows:


March 31, 2019March 31, 2018
Cash and cash equivalents$6,397 $12,762 
Restricted cash206 — 
Restricted cash in other assets472 473 
Cash, cash equivalents and restricted cash in the statement of cash flows$7,075 $13,235 
 June 30, 2018 December 31, 2017 June 30, 2017 December 31, 2016
Cash and cash equivalents$13,675
 $26,692
 $50,216
 $66,006
Restricted cash in other assets472
 473
 475
 475
Cash, cash equivalents and restricted cash in the statement of cash flows$14,147
 $27,165
 $50,691
 $66,481





Stock Based Compensation

ASC 718-10 defines the fair-value-based method of accounting for stock-based employee compensation plans and transactions used by the Company to account for its issuances of equity instruments to record compensation cost for stock-based employee compensation plans at fair value as well as to acquire goods or services from non-employees. Transactions in which the Company issues stock-based compensation to employees, directors and advisors and for goods or services received from non-employees are accounted for based on the fair value of the equity instruments issued. The Company utilizes pricing models in determining the fair values of options, restricted stock units ("RSU's") and warrants issued as stock-based compensation. These pricing models utilize the market price of the Company’s common stock and the exercise price of the option or warrant, as well as time value and volatility factors underlying the positions. Stock-based compensation expense is recognized over the requisite service period of the award, which usually coincides with the vesting period of the grant.


Fair Value of Financial Instruments
 
12

The carrying amounts of cash and cash equivalents, trade receivables, notes payable,restricted cash, accounts payable and other accrued liabilities at June 30, 2018March 31, 2019 approximate their fair value for all periods presented. The Company measures fair value in accordance with ASC 820-10, “Fair Value Measurements and Disclosures”.  ASC 820-10 clarifies that fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability.  As a basis for considering such assumptions, ASC 820-10 establishes a three-tier value hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value:
Level 1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date.
Level 2 Inputs: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability.
Level 3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at measurement date. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.

As of June 30, 2018,March 31, 2019, based on level 2 inputs, the net carryingfair value of the 2019our Notes (2019 Notes and 2023 Notes (collectively the "Notes" and discussed in Note 7)Notes) was approximately $115.7$64.3 million compared to their face value of $143.75 million. This variance is due to the conversion feature in the Notes rather than to changes in market interest rates. The Notes carry a fixed interest rate and therefore do not subject the Company to interest rate risk. As of June 30, 2018, the net carrying value of $69.9 million. In addition, the 2021 Term Loan (discussed in Note 7) was approximately $14.2 million compared to the face value of $15.0 million.our Senior Credit Facilities was stated at carrying value at March 31, 2019. The variance is due to debt discount and debt financing costs. The 2021 Term Loan bears interestCompany believes it could obtain borrowings at a rate of LIBOR plus 9%, and isMarch 31, 2019 with comparable terms as the December 31, 2018 Senior Credit Facilities, therefore, subject to market risk.the carrying value approximates fair value.


Loss Per Common Share
 
Basic loss per share of common stock is computed based on the weighted average number of shares of common stock outstanding during the period. Diluted loss per share of common stock is computed using the weighted average number of shares of common stock and potential dilutive common stock equivalents outstanding during the period. Potential dilutive common stock equivalents include shares issuable upon the conversion of the 2019notes and 2023 Notes, the exercise of options and the vesting RSU's.warrants. For the three and six months ended June 30, 2018,March 31, 2019, the potential dilutive common stock equivalents have been excluded from the computation of diluted loss per share, as their effect would have been anti-dilutive.


(in thousands except shares and per share data)

Three months ended June 30, Six months ended June 30,Three months ended March 31,
2018 (Restated) 2017 2018 (Restated) 201720192018
Basic loss per share computation: 
  
  
  
Basic loss per share computation:
Net loss - basic and diluted$(13,119) $(919) $(17,921) $(88)Net loss - basic and diluted$(8,724)$(4,802)
Weighted average common shares - basic and diluted53,510,712
 53,304,407
 53,484,756
 53,250,109
Weighted average common shares - basic and diluted53,805,983 53,458,513 
Basic and diluted loss per share$(0.25) $(0.02) $(0.34) $0.00
Basic and diluted loss per share$(0.16)$(0.09)

Revenue Recognition

The Company recognizes revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. The Company's revenue is recorded net of accruals for estimated chargebacks, rebates, cash discounts, other allowances, and returns. The Company derives its revenues from three types of transactions: sales of its own pharmaceutical products (Company product sales), sales of manufactured product for its customers (contract manufacturing sales), and research and product development services performed for third parties. Due to differences in the substance of these transaction types, the transactions require, and the Company utilizes, different revenue recognition policies for each. Taxes collected from customers and remitted to government authorities and that are related to the sales of the Company’s products are excluded from revenues. See more detailed information in Note 4.



Adoption of ASC Topic 606, "Revenue from Contracts with Customers”

In May 2014, the FASB issued ASU 2014-09, “Revenue from Contracts with Customers (Topic 606).” The standard, including subsequently issued amendments, replaces most existing revenue recognition guidance in U.S. GAAP. The key focus of the new standard is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services.

The Company performed a comprehensive review of its existing revenue arrangements as of January 1, 2018 following the aforementioned five-step model. Based on the Company's analysis, there were no changes identified that impacted the amount or timing of revenues recognized under the new guidance as compared to the previous guidance. Additionally, the Company's analysis indicated that there were no changes to how costs to obtain and fulfill our customer contracts would be recognized under the new guidance as compared to the previous guidance. The impact of the adoption of this standard on the Company's Condensed Consolidated Balance Sheet, Condensed Consolidated Statement of Operations, and Condensed Consolidated Statement of Cash Flows was not material. The adoption of the new guidance impacted the way the Company analyzes, documents, and discloses revenue recognition under customer contracts beginning on January 1, 2018 and resulted in additional disclosures in the Company's financial statements.

Property, Plant and Equipment

Depreciation and amortization of property, plant and equipment is provided for under the straight-line method over the assets’ estimated useful lives as follows:    
Useful Lives
Buildings and Improvements10 - 40 years
Machinery and Equipment5 - 15 years
Computer Hardware and Software3 - 5 years
Furniture Fixtures5 years
Leasehold improvements are amortized over the shorter of estimated useful life or the lease term. Repair and maintenance costs are charged to operations as incurred while major improvements are capitalized. Construction in progress ("CIP") costs are amortized based on the asset class when they are put into service. When assets are retired or disposed, the related cost and accumulated depreciation thereon are removed and any gains or losses are included in operating results.

Concentration of Credit Risk
 
Major customers of the Company are defined as those constituting greater than 10% of ourthe Company's total revenue. For the three months ended June 30, 2018,March 31, 2019, two of the Company’s customers accounted for 49%48% of the Company’s revenue, consisting of 35%30% and 14%18%, respectively. For the three months ended June 30, 2017,March 31, 2018, three of the Company’s customers accounted for 50%59% of the Company’s revenue, consisting of 26%38%, 10%11% and 14%, respectively. For the six months ended June 30, 2018, two of the Company's customers accounted for 48% of the Company's revenue, consisting of 35% and 13%, respectively. For the six months ended June 30, 2017, three of the Company's customers accounted for 52% of the Company's revenue, consisting of 26%, 13% and 13%10%, respectively. Accounts receivable related to the Company’s major customers comprised 49%37% of all accounts receivable as of June 30, 2018,March 31, 2019, and 67%52% of all accounts receivable as of June 30, 2017.March 31, 2018. The loss of one or more of these major customers could have a significant impact on our revenues and harm our business and results of operations.operations.
 
13

For the three months ended June 30, 2018,March 31, 2019, domestic net revenues were $11.4 million and foreign net revenues were $4.9 million. For the six months ended June 30, 2018, domestic net revenues were $21.6 million and foreign net revenues were $9.2 million. As of June 30, 2018, domestic assets were $125.9 million and foreign assets were $60.9 million. For the three months ended June 30, 2017, domestic net revenues were $13.0$9.7 million and foreign net revenues were $3.4 million. As of March 31, 2019, domestic assets were $135.5 million and foreign assets were $56.4 million. For the sixthree months ended June 30, 2017,March 31, 2018, domestic net revenues were $27.8$10.2 million and foreign net revenues were $6.3
$4.3 million.  As of June 30, 2017,March 31, 2018, domestic assets were $124.8$115.9 million and foreign assets were $68.7$65.2 million.


Foreign Currency Translation
The net assets of international subsidiaries where the local currencies have been determined to be the functional currencies are translated into U.S. dollars using current exchange rates. The U.S. dollar effects that arise from translating the net assets of these subsidiaries at changing rates are recorded in the foreign currency translation account, which is included in Accumulated Other Comprehensive (Loss) ("AOCI") and reflected as a separate component of equity. For those subsidiaries


where the U.S. dollar has been determined to be the functional currency, non-monetary foreign currency assets and liabilities are translated using historical rates, while monetary assets and liabilities are translated at current rates, with the U.S. dollar effects of rate changes included in Foreign currency exchange gain line item under the Other income (expense), net section of the Condensed Consolidated Statement of Operations.

Debt Issuance Costs
Expenses related to debt financing activities are capitalized and amortized on an effective interest method, over the term of the loan and are to be netted against the carrying value of the financial liability, as required by ASU 2015-3. This standard aligns the treatment of debt issuance costs and debt discounts in that both reduce the carrying value of the liability. Amortization of debt issuance costs is to be recorded as interest expense on the Condensed Consolidated Statement of Operations.

Adoption of Other RecentRecently Adopted Accounting Pronouncements

In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): "Restricted Cash (a consensus of the FASB Emerging Issues Task Force)". The update addresses the diversity in the industry with respect to classification and presentation of changes in restricted cash on the statement of cash flows. These amendments require that a statement of cash flows explain the restricted cash change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. The amendments in this update were effective for fiscal years beginning after December 15, 2017 for public business entities, including interim periods within those fiscal years. For the Company, the amendments were effective January 1, 2018. The Company's adoption of this ASU, effective January 1, 2018, did not have a significant impact on its consolidated financial statements.

In January 2017, the FASB issued ASU 2017-01, Business Combinations (Topic 805): “Clarifying the Definition of a Business”. The update clarifies the definition of a business, specifically for companies to better evaluate whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. The amendments in this update were effective for public companies for annual periods beginning after December 15, 2017, including interim periods within those annual periods. The Company's adoption of this ASU, effective January 1, 2018, did not have a significant impact on its consolidated financial statements.

In January 2017, the FASB issued ASU 2017-03, Accounting Changes and Error Corrections (Topic 250) and Investments—Equity Method and Joint Ventures (Topic 323): “Amendments to SEC Paragraphs Pursuant to Staff Announcements at the September 22, 2016 and November 17, 2016 EITF Meetings”. The update shows amendments to two SEC Announcements made late in 2016 regarding four specific standards as follows: ASU 2014-09, Revenue from Contracts with Customers (Topic 606), ASU 2016-02, Leases (Topic 842), ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), and ASU 2014-01, Investments - Equity Method and Joint Ventures (Topic 323). The amendments in this update require changes to the U.S. GAAP Financial Reporting Taxonomy and the changes will be incorporated into the proposed 2018 Taxonomy which are available for public comment and finalized as part of the annual release process. The Company's adoption of this ASU, effective January 1, 2018, did not have a significant impact on its consolidated financial statements.

In February 2017, the FASB issued ASU 2017-05, Other Income—Gains and Losses from the Derecognition of Nonfinancial Assets (Subtopic 610-20): “Clarifying the Scope of Asset Derecognition Guidance and Accounting for Partial Sales of Nonfinancial Assets”. This update addresses guidance for partial sales of nonfinancial assets. It affects (i) an entity that enters into a contract to transfer to a customer a nonfinancial asset, group of nonfinancial assets, or ownership interest in a consolidated subsidiary that is not a business or nonprofit entity, (ii) an entity that historically had transactions within the scope of the real estate-specific derecognition guidance, and (iii) an entity that contributes nonfinancial assets that are not a business or a nonprofit activity to a joint venture or other noncontrolled investee. The amendments were effective at the same time as the amendments in ASU 2014-09. Therefore, for the Company, the amendments were effective for annual reporting periods beginning after December 15, 2017, including interim reporting periods within that reporting period. Public entities may apply the guidance earlier but only as of annual reporting periods beginning after December 15, 2016, including interim reporting periods within that reporting period. The Company does not currently expect to enter into any such nonfinancial asset or ownership interest in its consolidated subsidiaries agreements but will refer to the guidance in ASU 2017-05 should that occur. The Company's adoption of this ASU, effective January 1, 2018, did not have a significant impact on its consolidated financial statements.

In May 2017, the FASB issued ASU 2017-09, Compensation—Stock Compensation (Topic 718): “Scope of Modification Accounting”. This update provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718, Compensation—Stock Compensation, to a change to the


terms or conditions of a share-based payment award. The amendments affect any entity that changes the terms or conditions of a share-based payment award. The amendments are effective for fiscal years beginning after December 15, 2017. For the Company, the amendments were effective January 1, 2018. The Company has not made any changes to the terms or conditions of share-based payment awards but will refer to the guidance in ASU 2017-09 should that occur. The Company's adoption of this ASU, effective January 1, 2018, did not have a significant impact on its consolidated financial statements.

Recently Issued Accounting Pronouncements


In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842): “Recognition and Measurement of Financial Assets and Financial Liabilities”., which supersedes the existing lease guidance under Topic 840. The update supersedes Topic 840, Leases andnew standard requires the recognition of leaselessees to recognize Right-of-Use ("ROU") assets and lease liabilities by lessees for all leases with terms greater than 12 months, including those leases that were previously classified as operating leases under previous GAAP.leases. Topic 842 retains a distinction between finance leases and operating leases, with measurement and presentation of expenses and cash payments from operating leases classified within operating activities inflows being dependent upon the statement of cash flows. The amendments in this update are effective for fiscal years beginning after December 15, 2018 for public business entities, which for the Company means January 1, 2019.classification. The Company is reviewing all lease agreements inclusive of supplier agreements. The Company is currently evaluatingadopted the impact of this ASU on its consolidated financial statements.

In January 2017, the FASB issued ASU 2017-04, Intangibles - Goodwill and Other (Topic 350): “Simplifying the Test for Goodwill Impairment”. The update simplifies how an entity is required to test goodwill for impairment by eliminating Step 2 from the goodwill impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill. It affects public entities that have goodwill reported in their financial statements and have not elected the private company alternative for the subsequent measurement of goodwill. A public entity that is a U.S. Securities and Exchange Commission ("SEC") filer should adopt the amendments in this update for its annual or any interim goodwill impairment tests in fiscal years beginning after December 15, 2019. For the Company, the amendments arenew standard effective January 1, 2020. The Company is currently evaluating2019 utilizing the impact of thisoptional transition method allowed under ASU on its consolidated financial statements.2018-11, Leases (Topic 842): Targeted Improvements. See Note 7 for the Company's additional required disclosures under Topic 842.


In February 2018, the FASB issued ASU 2018-02, “Income Statement - Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income,” which allows a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Cuts and Jobs Act. This guidance is effective for all entities for fiscal years, and interim periods within those years, beginning after December 15, 2018, with early adoption permitted. The amendments in ASU 2018-02 should be applied either in the period of adoption or retrospectively to each period in which the effect of the change in the U.S. federal corporate income tax rate in the Tax Cuts and Jobs Act is recognized. The Company's adoption of this guidance isASU, effective January 1, 2019, did not expected to have a material impact on its condensed consolidated financial statements.

Recently Issued Not Yet Adopted Accounting Pronouncements

In January 2017, the Company's Consolidated Financial StatementsFASB issued ASU 2017-04, Intangibles - Goodwill and related disclosures.Other (Topic 350): “Simplifying the Test for Goodwill Impairment”. The update simplifies how an entity is required to test goodwill for impairment by eliminating Step 2 from the goodwill impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill. For the Company, the amendments are effective January 1, 2020. The Company is currently evaluating the impact of this ASU on its condensed consolidated financial statements.


In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): “Clarifying the Interaction between Topic 808 and Topic 606”. The guidance clarifies that certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer. For the Company, the amendment will be effective January 1, 2020. The Company is currently evaluating the impact this guidance will have on its consolidated financial statements.

14

4. Revenues, Recognition and Allowances


Revenue Recognition

As of January 1, 2018, the Company adopted the ASC 606 guidance for revenue recognition for contracts, using the modified retrospective method. The implementation of this guidance had no material impact on the measurement or recognition of revenue from customer contracts of prior periods.
Upon adoption of this new guidance, the Company recognizes revenue using the following five steps:
•Identification of the contract, or contracts, with a customer;
•Identification of the performance obligations in the contract;
•Determination of the transaction price, including the identification and estimation of variable consideration;
•Allocation of the transaction price to the performance obligations in the contract; and
•Recognition of revenue when we satisfy a performance obligation.


The Company derives its revenues from three types of transactions: sales of its own pharmaceutical products (Company product sales), sales of manufactured product for its customers (contract manufacturing sales), and research and product development services performed for third parties.


Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the


transaction price using the expected value method based on historical experience as well as applicable information currently available.


Company Product Sales


Revenue from Company product sales is recognized upon transfer of control of a product to a customer at a point in time, generally as the Company's products are sold on an FOB destination basis and because inventory risk and risk of ownership passes to the customer upon delivery.


Company product sales are recorded net of accruals for estimated chargebacks, rebates, cash discounts, other allowances, and returns (collectively, sales returns and allowances or “SRA”).returns.
 
Contract Manufacturing Sales


The Company recognizes revenue for contract manufacturing sales upon transfer of control of a product to a customer, which is generally upon shipment of products. However, with the new adoption of revenue recognition for contracts, the Company recognizes the revenue over time, rather than upon shipment. These shipmentsover-time, as milestones are achieved. Shipments are made in accordance with sales commitments and related sales orders entered into with customers either verbally or in written form.


Contract manufacturing sales are recognized net of accruals for cash discounts and returns which are established at the time of sale, and are included in revenues,Revenue, net in the Company's Condensed Consolidated Statement of Operations.


Research and Development Services and Other Income


The Company establishes agreed upon product development agreements with its customers to perform product development services. Revenues are recognized in accordance with the agreement upon the completion of the phases of development and when the Company has no future performance obligations relating to that phase of development. Other types of revenue include royalty or licensing revenue, and would be recognized over time, or at a point in time, based upon the contractual term upon completion of the earnings process.  Judgments are required to evaluate contingencies such as potential variances in schedule and the costs, the impact of change orders, liability claims, contract disputes and achievement of contractual performance standards.


Revenues by Transaction Type


The Company operates in one reportable segment and, therefore, the results of the Company's operations are reported on a consolidated basis, for purposes of segment reporting, consistent with internal management reporting for the chief decision makers.

Net Sales (in thousands)revenues for the three and six months ended June 30,March 31, 2019 and 2018 and 2017 were as follows (prior-period amounts are not adjusted under the modified-retrospective method of adoption):follows:

Three Months Ended March 31,
20192018
Company product sales$12,495 $13,236 
Contract manufacturing sales542 1,298 
Research and development services and other income85 11 
Revenue, net$13,122 $14,545 

15
 Three months ended June 30, Six months ended June 30,
 2018 2017 2018 2017
Company product sales$14,677
 $13,912
 $27,913
 $28,120
Contract manufacturing sales1,450
 2,407
 2,748
 5,824
Research and development services and other income122
 113
 $133
 $151
Revenue, net$16,249
 $16,432
 $30,794
 $34,095


Disaggregated information for the Company product sales revenue has been recognized in the accompanying unaudited interim Condensed Consolidated Statements of Operations, and is presented below according to contract type (in thousands):type:

 Three months ended June 30, Six months ended June 30,Three Months Ended March 31,
Company Product Sales 2018 2017 2018 2017Company Product Sales20192018
Topical $7,888
 $8,558
 $15,795
 $16,153
Topical$9,032 $7,908 
Injectables 6,789
 5,354
 12,118
 11,967
Injectables3,463 5,328 
Total $14,677
 $13,912
 $27,913
 $28,120
Total$12,495 $13,236 




In the sixthree months ended June 30, 2018,March 31, 2019, the Company did not incur, and therefore did not defer, any material incremental costs to obtain contracts.


Sales Returns and Allowances


As is customary in the pharmaceutical industry, the Company’s product sales are subject to a variety of deductions including chargebacks, rebates, cash discounts, other allowances, and returns. Product sales are recorded net of accruals for SRA,returns and allowances, which are established at the time of sale. The Company analyzes the adequacy of its accruals for SRAreturns and allowances quarterly. Amounts accrued for sales deductions are adjusted when trends or significant events indicate that an adjustment is appropriate. Accruals are also adjusted to reflect actual results. These provisions are estimates based on historical payment experience, historical relationship to revenues, estimated customer inventory levels and current contract sales terms with direct and indirect customers. The Company uses a variety of methods to assess the adequacy of its SRAreturns and allowances reserves to ensure that its financial statements are fairly stated. These include periodic reviews of customer inventory data, customer contract programs, subsequent actual payment experience, and product pricing trends to analyze and validate the SRAreturn and allowances reserves.


Net Company product sales of $14.7 million and $13.9 million for the three months ended June 30, 2018 and 2017, respectively, are included in product sales, net in the Condensed Consolidated Statements of Operations. Net Company product revenue of $27.9 million and $28.1 million for the six months ended June 30, 2018 and 2017, respectively, are included in product sales, net in the Condensed Consolidated Statements of Operations. Accounts receivable arebalance was presented net of SRA balances of $19.3sales returns and allowances, which was $13.7 million and $33.7$18.1 million at June 30,March 31, 2019 and December 31, 2018 respectively. In addition, the allowance for doubtful accounts was $2.5 million and 2017,$2.6 million at March 31, 2019 and December 31, 2018, respectively. For the six months ended June 30, 2018, the Company recorded income of $0.8 million due to a decrease in the Medicaid reserveThe allowance for doubtful accounts was primarily related to finalizingone specific customer in the payment per the termsamount of the product acquisition agreement.$1.7 million.


The accrual for chargebacks isChargebacks are one of the Company's most significant estimates for recognition of product sales. A chargeback represents an amount payable in the future to a wholesaler for the difference between the invoice price paid to the Company by its wholesale customer for a particular product and the negotiated contract price that the wholesaler’s customer pays for that product. The Company’s chargeback provision and related reserve varies with changes in product mix, changes in customer pricing and changes to estimated wholesaler inventories. The provision for chargebacks also takes into account an estimate of the expected wholesaler sell-through levels to indirect customers at contract prices. The Company validates the chargeback accrual quarterly through a review of the inventory reports obtained from its largest wholesale customers. This customer inventory information is used to establish the estimated liability for future chargeback claims based on historical chargeback and contract rates. These large wholesalers represent a majority of the Company’s chargeback payments. The Company continually monitors current pricing trends and wholesaler inventory levels to ensure the liability for future chargebacks is fairly stated.


The rebate accrual isRebates are used for various discounts and rebates provided to customers. This account has been used for variouswhich can be programs or one-time discounts given to customers.event. The Company reviews the percentage of products sold through these programs by reviewing chargeback data and uses the appropriate percentages to calculate the rebate accrual. Rebates are invoiced monthly, quarterly or quarterlyannually and reviewed against the accruals. Other items that could be included in accrued rebates would be price protection fees, shelf stock adjustments (SSAs), or other various amounts that would serve as one time discounts on specific products.


Consistent with its cash management strategy, the Company reduced the price paid by wholesalers (also referred to as the “WAC” or wholesaler acquisition cost) on several of its products in the second and third quarters of 2018. As a result, its gross product sales and related chargebacks and billbacks are reduced accordingly. The Company's adjustments for the deductions to gross product sales are as follows (in thousands):follows:

16

Three months ended June 30, Six months ended June 30,Three Months Ended March 31,
2018 2017 2018 201720192018
Gross product sales$48,142
 $66,744
 $84,690
 $121,044
Gross product sales$27,414 $36,548 
       
Deduction to gross product sales: 
  
  
  
Deduction to gross product sales:
Chargebacks and billbacks21,449
 44,090
 38,364
 74,105
Chargebacks and billbacks10,886 16,915 
Wholesaler fees for service477
 1,976
 1,112
 4,204
Wholesaler fees for service1,766 635 
Sales discounts and other allowances11,539
 6,766
 17,301
 14,615
Sales discounts and other allowances2,267 5,762 
Total reduction to gross product sales$33,465
 $52,832
 $56,777
 $92,924
Total reduction to gross product sales$14,919 $23,312 
       
Company product sales, net$14,677
 $13,912
 $27,913
 $28,120
Company product sales, net$12,495 $13,236 


Financing and Payment




The Company's payment terms vary by the type and location of the customer and the products or services offered. The term between invoicing and when payment is due is not significant. TheGenerally, the Company generally does not haveincur incremental costs to obtain contracts that would otherwise not have been incurred.contracts. The Company does not adjust revenue for the promised amount of consideration for the effects of a significant financing component becauseas the Company's customers generally pay the Company within 100 days.


Costs to Obtain or Fulfill a Customer Contract

Sales commissions are expensed when incurred because the amortization period would have been one year or less. These costs are recorded in selling, general and administrative expense in the Condensed Consolidated Statements of Operations.
Costs related to shipping and handling isare comprised of outbound freight and associated labor. The Company accounts for shipping and handling activities related to contracts with customers as fulfillment costs which are included in cost of sales in the Condensed Consolidated Statements of Operations.


In connection with four of the 30 products the Company currently manufactures, markets and distributes in its own label in the U.S., in accordance with an agreement entered into in December of 2011, theThe Company is required to pay a 40% royalty calculated based on certain product net sales to one of its pharmaceutical partners. The royalty is calculated based on contracted terms of 40% of net sales for the four products, which is to be paid quarterly to thea pharmaceutical partner. Accounts payableThere are currently 4 products manufactured and accrued expenses include $0.6 million and $0.4 million at June 30, 2018 and 2017, respectively, relateddistributed under the Company’s label in the U.S. which are subject to these royalties.this agreement. Payments are made quarterly. Royalty expense of $0.7$0.3 million and $0.4$0.8 million was included in cost of sales in the Condensed Consolidated Statements of Operations for the three months ended June 30,March 31, 2019 and 2018, and 2017, respectively. Royalty expense of $1.5 million and $0.9 million was included in cost of sales in the Condensed Consolidated Statements of Operations for the six months ended June 30, 2018 and 2017, respectively.



17

5.  Inventories


Inventories are valued at the lower of cost or net realizable value, using the first-in-first-out method and consist of the following (in thousands):following:


March 31, 2019December 31, 2018
Raw materials$12,629 $10,456 
Work in progress77 116 
Finished goods11,368 8,391 
Inventories reserve(3,120)(2,667)
Inventories, net$20,954 $16,296 


18

 June 30, 2018 December 31, 2017
 (Unaudited) (Audited)
Raw materials$10,655
 $8,231
Work in progress944
 616
Finished goods8,434
 8,532
Inventories reserve(2,458) (1,304)
Inventories, net$17,575
 $16,075


6.  Property, Plant and Equipment
 
Property, plant and equipment consists of the following (in thousands):following:
June 30, 2018 December 31, 2017
(Unaudited) (Audited)March 31, 2019December 31, 2018
Land$257
 $257
Land$401 $401 
Building and improvements17,474
 8,613
Building and improvements53,810 53,813 
Machinery and equipment9,674
 9,142
Machinery and equipment12,358 12,229 
Computer hardware and software4,059
 3,244
Computer hardware and software4,586 4,182 
Furniture and fixtures553
 449
Furniture and fixtures687 694 
Construction in progress60,531
 55,017
Construction in progress33,911 30,949 
92,548
 76,722
105,753 102,268 
Less accumulated depreciation and amortization(9,258) (8,367)Less accumulated depreciation and amortization(11,361)(10,493)
Property, plant and equipment, net$83,290
 $68,355
Property, plant and equipment, net$94,392 $91,775 
 


The Company recorded depreciation expense of $1.1$0.9 million and $0.8$0.6 million for the sixthree months ended June 30,March 31, 2019 and March 31, 2018, and June 30, 2017, respectively. During the three months ended June 30,March 31, 2019 and March 31, 2018, and June 30, 2017, there was $1.5 million of interestzero and $0.7$1.3 million of interest, respectively, capitalized intoas construction in progress. For the six months ended June 30, 2018 and June 30, 2017, there was $2.8 million of interest and $1.2 million of interest, respectively, capitalized into construction in progress. This increase in capitalized interest is related to outstanding costs for the Company's facility expansion project in Buena. DuringIn addition, during the three months ended June 30,March 31, 2019 and March 31, 2018, and June 30, 2017, there was $0.7$0.3 million of payroll costs and $0.2 million of payroll costs, respectively, capitalized into construction in progress. For the six months ended June 30, 2018 and June 30, 2017, there was $1.1 million of payroll costs and $0.4 million of payroll costs, respectively, capitalized intoas construction in progress.
19

7.  Leases 

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which supersedes the existing lease guidance under Topic 840. The new standard requires lessees to recognize Right-of-Use ("ROU") assets and lease liabilities for all leases with terms greater than 12 months, including those leases that were previously classified as operating leases. Topic 842 retains a distinction between finance leases and operating leases, with measurement and presentation of expenses and cash flows being dependent upon the classification. The Company adopted the new standard on January 1, 2019 utilizing the optional transition method allowed under ASU 2018-11, Leases (Topic 842): Targeted Improvements.

The Company elected to adopt the package of practical expedients allowed under the new accounting guidance, which allows the Company to not reassess previous conclusions regarding 1) whether existing or expired leases are or contain leases 2) the lease classification of existing or expired leases and 3) initial direct costs for existing leases. In addition, the Company adopted the practical expedient to combine lease and non-lease components for all classes of underlying assets.

The Company reviewed its portfolio of lease agreements, and other service contracts to identify embedded leases, and reached conclusions on key accounting assessments related to the standard and finalized the related accounting policies. As a result of the implementation of the new standard, all leases with a term greater than 12 months previously classified as operating leases and only expensed through the Consolidated Statements of Operations are now recorded on the Consolidated Balance Sheets. Per the requirements of the standard the Company has recorded a ROU asset and a lease liability representing the present value of future lease payments to be paid in exchange of the use of an asset of $2.8 million and $3.0 million respectively as of January 1, 2019. However, there was no cumulative effect adjustment to the opening balance of retained earnings as the assets and the liabilities recorded upon adoption off-set each other.

We have operating and finance leases for our corporate, manufacturing and international facilities as well as certain equipment. Our leases have remaining terms of less than one year to up to 10 years, some of which include options to extend the leases for up to 5 years and one of which have an early termination option at any time. As the interest rates implicit in our leases are typically not readily determinable, the Company has elected to utilize an incremental borrowing rate as the discount rate, determined based on the expected term of the lease, the Company’s credit risk and existing borrowings. The discount rates utilized ranged from 4.86% to 8.60% and were utilized to determine the present value of the lease liabilities.

The components of lease expense were as follows:

March 31, 2019
Operating lease cost$159 
Finance lease cost:
Amortization of right-of-use assets3
Interest on lease liabilities2
Total finance lease cost$5 

Right-of-use assets obtained in exchange for new operating lease liabilities was $1.0 million as of March 31, 2019. Cash paid for amounts included in the measurement of operating lease liabilities during the three months ended March 31, 2019 was $0.1 million. Cash paid for amounts included in the measurement of finance lease liabilities during the three months ended March 31, 2019 was not material.


Supplemental balance sheet information related to leases were as follows:

20

March 31, 2019
Operating Leases
Other assets$2,746 
Other current liabilities395 
Other long-term liabilities2,512 
Total operating lease liabilities2,907 
Finance Leases
Property, plant, and equipment81 
Accumulated depreciation(3)
Property, plant, and equipment, net78 
Other current liabilities12 
Other long-term liabilities67 
Total finance lease liabilities$79 

The weighted average remaining lease terms for operating and financing leases are 6.8 years and 5.4 years, respectively. The weighted average discount rates for operating and finance leases are 8.18% and 7.97%, respectively.

As of March 31, 2019 maturities of lease liabilities were as follows:
OperatingFinancing
Year Ending December 31,LeasesLeases
2019 (excluding the three months ended March 31, 2019)$458 $13 
2020631 18 
2021607 18 
2022548 18 
2023547 18 
2024235 12 
Thereafter839 — 
Total lease payments3,865 97 
Less imputed interest958 18 
Total$2,907 $79 

As previously disclosed in our 2018 Annual Report on Form 10-K and under the previous lease accounting standard, future minimum lease payments for operating leases having initial or remaining noncancellable lease terms in excess of one year would have been as follows:

21

Commitments
2019$573 
2020611 
2021633 
2022610 
2023607 
2024200 
$3,234 

22

8.  Debt


Convertible Notes


On December 16, 2014, the Company issued $125.0 million aggregate principal amount of Convertible 3.75% Senior Notes, due 2019 (the “2019 Notes”). On December 22, 2014, the Company announced the closing of the initial purchasers’ exercise in full of their option to purchase an additional $18.75 million aggregate principal amount of 2019 Notes. The 2019 Notes bear interest at a fixed rate of 3.75% per year, payable semiannually in arrears on June 15 and December 15 of each year, beginning on June 15, 2015, and mature on December 15, 2019, unless earlier repurchased, redeemed or converted. The 2019 Notes are convertible into shares of the Company’s common stock, cash or a combination thereof. On May 20, 2015, the Company received shareholder approval for the increase in the number of shares of common stock authorized and available for issuance upon conversion of the 2019 Notes.


On April 27, 2018, the Company entered into separate exchange agreements with certain holders of the 2019 Notes. The agreements gave the holders the right to exchange, in aggregate, $75.1 million of the 2019 Notes for $75.1 million of new Convertible 4.75% Senior Notes due 2023 (the “2023 Notes”). The new 2023 Notes bear a fixed interest rate of 4.75% per year, payable semi-annually with the principal payable in May 2023. At the option of the holders, the 2023 Notes are convertible into shares of the Company’s common stock, cash or a combination thereof. The initial conversion rate is $224.71 per share, subject to certain adjustments, related to either the Company's stock price volatility, or the Company's declaration of a stock dividend, stock distribution, share combination or share split expected dividends or other anti-dilutive activities. In addition, holders will be entitled to receive additional shares of common stock for a potential increase of the conversion rate up to $280.90 per share under a make-whole provision in some circumstances. The Company incurred loan issue costs of $1.6 million upon issuance of the 2023 Notes.


In accordance with accounting for convertible debt within the cash conversion guidance of ASC 470-20, we allocated the principal amount of the 2023 Notes between its liability and equity components. The carrying amount of the liability component was determined by measuring the fair value of a similar debt instrument of similar credit quality and maturity that did not have the conversion feature. The carrying amount of the equity component, representing the embedded conversion option, was determined by deducting the fair value of the liability component from the principal amount of the 2023 Notes as a whole. The equity component was recorded to additional paid-in capital and is not remeasured as long as it continues to meet the conditions for equity classification. The excess of the principal amount of the 2023 Notes over the carrying amount of the liability component was recorded as a debt discount of $19$19.0 million, and is being amortized to interest expense using the effective interest method through the maturity date. We allocated the total amount of transaction costs incurred to the liability and equity components using the same proportions as the proceeds from the 2023 Notes. Transaction costs attributable to the liability component were recorded as a direct deduction from the liability component of the 2023 Notes, and are being amortized to interest expense using the effective interest method through the maturity date. Transaction costs attributable to the equity component were netted with the equity component of the 2023 Notes in additional paid-in capital. The effective interest rate of the 2023 Notes, inclusive of the debt discount and issuance costs, is 12.10%11.90%.


The exchange of $75.1 million of the 2019 Notes for the 2023 Notes is considered an extinguishment under ASC 470-50. The 2019 Notes are accounted for under cash conversion guidance ASC 470-20, which requires the Company to allocate the fair value of the consideration transferred upon settlement to the extinguishment of the liability component and the reacquisition of the equity component upon derecognition.  In accordance with the aforementioned guidance, the Company recorded $2.5 million of non-cash interest expense as an extinguishment loss related to the 2019 Notes in the Condensed Consolidated Statement of Operations. In addition the Company recorded a $7.6 million reduction of Additional Paid in Capital in connection with the extinguishment of $75.1 million of the 2019 Notes.


Term LoanIn December 2018 the Company used $52.8 million of proceeds from the Senior Credit Facilities (see below) to repurchase the 2019 Notes as well as $0.3 million of proceeds to pay for transaction costs. The repurchase of the 2019 Notes is considered a debt extinguishment under ASC 470-50. The 2019 Notes are accounted for under cash conversion guidance ASC 470-20, which requires the Company to allocate the fair value of the consideration transferred upon settlement to the extinguishment of the liability component and the reacquisition of the equity component upon derecognition. In accordance with the guidance above, the Company allocated a portion of the $52.8 million to the extinguishment of the liability component equal to the fair value of that component immediately before extinguishment and recognized a $1.7 million extinguishment loss in the Consolidated Statement of Operations to measure the difference between (i) the fair value of the liability component and (ii) the net carrying value amount of the liability component (which is net of any unamortized debt issuance costs). In addition, the Company recorded a $2.9 million reduction of Additional Paid in Capital in connection with the extinguishment of the 2019 Notes.



23


In January and February of 2019, the Company used a total of $2.7 million of proceeds from the Senior Credit Facilities to repurchase a portion of the remaining 2019 Notes. The repurchase of the 2019 Notes is considered a debt extinguishment under ASC 470-50. The 2019 Notes are accounted for under cash conversion guidance ASC 470-20, which requires the Company to allocate the fair value of the consideration transferred upon settlement to the extinguishment of the liability component and the reacquisition of the equity component upon derecognition.  In accordance with the guidance above, the Company allocated a portion of the $2.7 million to the extinguishment of the liability component equal to the fair value of that component immediately before extinguishment and recognized a $0.2 million extinguishment loss in the Consolidated Statement of Operations to measure the difference between (i) the fair value of the liability component and (ii) the net carrying value amount of the liability component (which is already net of any unamortized debt issuance costs). In addition, the reduction of Additional Paid in Capital in connection with this extinguishment was immaterial.

Senior Credit Facilities

On June 1,December 13, 2018, the Company entered into a credit agreement for $25.0 million secured by all Company assets, due June 1, 2021 (“2021Revolving Credit Agreement (the “Revolver”) and Term Loan Agreement (the “2023 Term Loan”, and together with the Revolver, the “Senior Credit Facilities”). The 2021 Term Loan has limitedconsists of (i) a $50.0 million initial term loan (the “Initial Term Loan”); (ii) a $30.0 million delayed draw term loan A (the “Delayed Draw Term Loan A”) and (iii) a $15.0 million delayed draw term loan B (the “Delayed Draw Term Loan B” and, together with the Delayed Draw Term Loan A, the “Delayed Draw Term Loans”). The Initial Term Loan matures on the earlier to occur of (a) three months prior to maturity of the 2023 Notes and (b) June 13, 2024. Commitments related to undrawn amounts of the Delayed Draw Term Loan A terminate on June 30, 2019, and drawn amounts under the Delayed Draw Term Loans mature at the same time as the Initial Term Loan. The Revolver matures on the earlier to occur of (a) six months prior to the maturity of the 2023 Notes and (b) December 13, 2023. The Company’s ability to borrow under the Revolver is subject to a borrowing base determined based upon eligible inventory, eligible equipment, eligible real estate and eligible receivables. The Senior Credit Facilities are secured by substantially all of the Company’s assets. All of the Company’s debt is subordinated to the Senior Credit Facilities. The 2023 Term Loan is subordinate to the Revolver. The Senior Credit Facilities have customary financial and non-financial covenants, inclusiveincluding affirmative, negative and reporting covenants, representations and warranties, and events of default, including cross-defaults on other material indebtedness, as well as events of default triggered by a change of control and certain actions initiated by the FDA. The financial covenants consist of a minimum revenue test, a minimum adjusted EBITDA test and a maximum total net leverage ratio.

The interest rate under the Revolver is calculated, at the option of the Company, at either the one, two, three or six-month London Inter-Bank Offered Rate (or LIBOR) plus 3.75% or the base rate plus 2.75%. The interest rate on the 2023 Term Loan is calculated, at the option of the Company, at either the one, two, three or six-month LIBOR plus 8.75% or the base rate plus 7.75%. Interest on the Senior Credit Facilities is payable in cash carry balanceexcept that interest on the 2023 Term Loan is payable, at the option of $5.0 million. The 2019 Notes and 2023 Notes are subordinatethe Company, in cash or in kind by being added to the 2021principal balance thereof, until the earlier of December 13, 2020 and the date the Company has provided the lenders of the Senior Credit Facilities financial statements demonstrating that the Company has attained twelve months of revenue of at least $125.0 million. A commitment fee of 1.0% per annum is payable by the Company quarterly in arrears on the unused portion of the Delayed Draw Term Loan. The first $15.0 millionLoans.

Amounts drawn under the Revolver may be prepaid at the option of loan proceeds was receivedthe Company without premium or penalty, subject, in the case of acceleration of the Revolver or termination of the revolving credit commitments thereunder, to certain call protections which vary depending on June 1, 2018. The remaining loan proceeds of $10.0 million werethe time at which such prepayments are made. Amounts drawn under the Revolver are subject to closingmandatory prepayment to the extent that aggregate extensions under the Revolver exceed the lesser of the revolving credit commitment then in effect and the borrowing base then in effect, and upon the occurrence of certain events and conditions, as defined inincluding non-ordinary course asset dispositions, receipt of certain insurance proceeds and condemnation awards and issuances of certain debt obligations. Amounts outstanding under the agreement and were received on July 16, 2018. The 20212023 Term Loan may be prepaid at the option of the Company subject to applicable premiums, including a make-whole premium, and certain call protections which vary depending on the time at which such prepayments are made. Subject to payment of outstanding obligations under the Revolver as a result of any corresponding mandatory prepayment requirements thereunder, amounts outstanding under the 2023 Term Loan are subject to mandatory prepayment upon the occurrence of certain events and conditions, including non-ordinary course asset dispositions, receipt of certain insurance proceeds and condemnation awards, issuances of certain debt obligations and a change of control transaction.

In connection with the Revolver the Company incurred loan issue costsa debt discount of $0.5 million and a discountdebt issuance issue costs of $0.4$0.3 million. The debt discount is duerelates to annual fees and lender fees paid on the initial drawdown of $15.0 million. The debt issuance costs and debt discount are recorded as an asset on the Consolidated Balance Sheet and are amortized to interest expense using the straight-line method through the estimated Revolver maturity date. The annual fees related to
24

the Revolver and the Initial Term Loan are amortized to interest expense using the straight-line method over the annual period they relate to. In connection with the Initial Term Loan and Delayed Draw Term Loan A, the Company incurred a debt discount of $1.8 million and debt issuance issue costs of $0.8 million. The debt discount is due to lender fees paid on the Initial Term Loan of $50.0 million and drawdown of Delayed Draw Term Loan A of $20.0 million. The debt issuance costs and debt discount costs are recognized asamortized to interest expense using the effective interest rate method through the estimated maturity date.  In addition, the Company incurred $0.5 million of debt issuance costs related to the commitment fees paid to the lenders for the undrawn amounts of the Delayed Draw Term Loans. These debt issuance costs are recorded as an asset on the balance sheet and amortized on a straight-line basis over the termaccess period of the 2021Delayed Draw Term Loan. The 2021 Term Loan bears interest at a rateLoans through June 30, 2019. As of LIBOR plus 9%, with a stated floor of 2%. TheDecember 31, 2018, the effective interest, inclusive of the debt discounts and issue costs, of the Revolver and Initial Term Loan and Delayed Draw Term Loan A is 12.78% 13.56% per year.9.3% and 12.4%, respectively. 


The Initial Term Loan of $50.0 million and $15.0 million of the Revolver were drawn by the Company on December 13, 2018. On December 21, 2018, the Company drew $20.0 million of the Delayed Draw Term Loan A. In addition, in January 2019, the Company drew $5.0 million from the remaining $10.0 million Revolver. As of March 31, 2019, the $10.0 million of the Delayed Draw Term Loan A, $15.0 million of the Delayed Draw Term Loan B and $5.0 million of the Revolver remain available to the Company. In April 2019, the Company drew down the remaining $5.0 million Revolver. The 2023 Term Loan and the 2023 Delayed Draw Term Loan bear interest at either the one, two, three or six-month at a rate of LIBOR plus 8.75% or base rate plus 7.75%, with a 24-month paid-in-kind interest option available to the Company should it choose to defer cash payments in order to maintain the liquidity needed to continue launching new products, and preparing for an FDA prior approval inspection of its new injectable manufacturing capability. As of March 31, 2019, the Company elected the paid-in-kind interest option and increased the principal balance of 2023 Term Loan by $2.0 million to $72.0 million.

The Ares Senior Credit Facilities require that the Company remains in compliance with certain financial performance covenants including a trailing-twelve-month minimum revenue through June 30, 2019, which then transitions to a trailing-twelve-month EBITDA from September 30, 2019 through September 30, 2020 which then finally transitions to a leverage ratio through expiration of the facility. Pursuant to the Ares Credit Agreement, in the event of a default related to the failure to meet certain covenants, the lender shall have the right, but not the obligation, to permanently reduce the commitment in whole or in part or to declare all or any portion of the outstanding balance to become due and payable. The Company will continuously monitor its compliance with the covenants contained in its Credit Agreement.

At June 30, 2018March 31, 2019 and December 31, 2017,2018, the net carrying value of the debt and the remaining unamortized debt discounts and debt issuance costs were as follows (in thousands):follows:


March 31, 2019December 31, 2018
Face amount of the 2019 Notes (due December 2019)$13,022 $15,702 
Less unamortized discounts and debt issuance costs(808)(1,291)
Total net carrying value$12,214 $14,411 
March 31, 2019December 31, 2018
Face amount of the 2023 Notes (due May 2023)$75,090 $75,090 
Face amount of the Revolver Credit Facility (due December 2022)20,000 15,000 
Face amount of the 2023 Loan (due February 2023)72,020 70,000 
Total carrying value, non-current167,110 160,090 
Less unamortized discounts and debt issuance costs(19,621)(20,519)
Total net carrying value, non-current$147,489 $139,571 


 June 30, 2018 December 31, 2017
 (Unaudited) (Audited)
Face amount of the 2019 Notes (non-current due December 2019)$68,660
 $143,750
Face amount of the 2021 Loan (non-current due June 2021)15,000
 —
Face amount of the 2023 Notes (non-current due May 2023)75,090
 —

158,750
 143,750
Less unamortized discounts and debt issuance costs28,871
 22,773
   Total Carrying Value, Net$129,879
 $120,977
For the six months ended June 30, 2018 and 2017, the Company recorded the following expenses in relation to the debt (in thousands):
 Three months ended June 30, Six months ended June 30,
 2018 2017 2018 2017
Interest expense of the 2019 Notes (1)$878
 $1,347
 $2,226
 $2,695
Interest expense of the 2021 Loan141
 —
 141
 —
Interest expense of the 2023 Notes (1)634
 —
 634
 —
Debt partial extinguishment of 2019 Notes2,467
 —
 2,467
 —
Debt discount amortization of the 2019 Notes (1)1,571
 2,126
 3,910
 4,183
Debt discount amortization of the 2021 Loan14
 —
 14
 —
Debt discount amortization of the 2023 Notes (1)498
 —
 498
 —
Debt financing amortization of the 2019 Notes (1)191
 232
 446
 456
Debt financing amortization of the 2021 Loan17
 —
 17
 —
Debt financing amortization of the 2023 Notes (1)42
 —
 42
 —
   Interest expense$6,453
 $3,705
 $10,395
 $7,334

(1) Included within "Interest and other expense, net" on the Condensed Consolidated Statements of Operations, offset by interest income and capitalized interest, as disclosed Note 6.

8.9. Goodwill and Intangible Assets


Goodwill
 
The Company acquired the assets of Canadian pharmaceutical company Alveda Pharmaceuticals, Inc., in November 2015. As a result of the acquisition, we recorded goodwill of $0.4 million. We assessassesses the recoverability of the carrying value of goodwill in the fourth quarteron a reporting unit basis on October 1 of each year, and whenever events occur or changes in circumstances change that would, more likely than not, reduceindicate the faircarrying value of our reporting unit below its carrying value. goodwill may not be recoverable.  
25

There have been no events or changes in circumstances that would have reducedindicate the faircarrying value of our reporting unit below its carrying value from Decembergoodwill may not be recoverable through March 31, 2017, through June 30, 2018. No impairment losses were recognized during the six months ended June 30, 2018.2019.
 



Changes to the carrying value in goodwill during the sixthree months ended June 30, 2018March 31, 2019 and the year endingended December 31, 2017 2018
were as follows (in thousands):follows: 


Goodwill
Goodwill balance at December 31, 2017$471 
Foreign currency translation(1)
Goodwill balance at December 31, 2018$470 
Foreign currency translation10 
Goodwill balance at March 31, 2019$480 
 Goodwill
Goodwill balance at December 31, 2016$446
Foreign currency translation25
Goodwill balance at December 31, 2017471
Foreign currency translation(26)
Goodwill balance at June 30, 2018$445

Intangible Assets
 
The following sets forth the major categories of the Company’s intangible assets and the weighted-average remaining amortization period as of June 30, 2018March 31, 2019 and December 31, 2017 (in thousands).2018.



June 30, 2018 March 31, 2019
Gross Carrying
Amount		 Accumulated
Amortization		 Net Carrying
Amount		 Weighted Average
Remaining Amortization
Period (Years)		Gross Carrying
Amount		Accumulated
Amortization		Net Carrying
Amount		Weighted Average
Remaining Amortization
Period (Years)
Trademarks and Technology$39,294
 $(6,875) $32,419
 12.4Trademarks and Technology$39,607 $(8,904)$30,703 11.5
Product acquisition costsProduct acquisition costs13,086 — 13,086 N/A- See description below
In process research and development ("IPR&D")17,831
 —
 17,831
 N/AIn process research and development ("IPR&D")649 — 649 N/A- See description below
Customer relationships3,637
 (957) 2,680
 7.6Customer relationships3,610 (1,230)2,380 6.6
Total$60,762
 $(7,832) $52,930
  Total$56,952 $(10,134)$46,818 


December 31, 2018
Gross Carrying
Amount		Accumulated
Amortization		Net Carrying
Amount		Weighted Average
Remaining Amortization
Period (Years)
Trademarks and Technology$40,169 $(8,239)$31,930 11.8
Product acquisition costs13,308 — 13,308 N/A- See description below
In-process research and development ("IPR&D")719 — 719 N/A- See description below
Customer relationships3,557 (1,139)2,418 6.9
Total$57,753 $(9,378)$48,375 
 December 31, 2017  
 Gross Carrying
Amount		 Accumulated
Amortization		 Net Carrying
Amount		 Weighted Average
Remaining Amortization
Period (Years)
Trademarks and Technology$40,380
 $(5,684) $34,696
 12.8
In-process research and development ("IPR&D")18,311
 —
 18,311
 N/A
Customer relationships3,783
 (773) 3,010
 7.9
Total$62,474
 $(6,457) $56,017
  


Changes in intangibles during the six months ended June 30, 2018 were as follows (in thousands):

 Trademarks and Technology IPR&D Customer Relationships
Balance at January 1, 2018$34,696
 $18,311
 $3,010
Amortization(1,363) —
 (187)
Loss on impairment(7) (15) —
Foreign currency translation(907) (465) (143)
Balance at June 30, 2018$32,419
 $17,831
 $2,680
Assuming no additions, disposals or adjustments are made to the carrying values and/orThe useful lives of the intangible assets, annual amortization expense on product rightsCompany’s intangibles are as follows:

Intangibles CategoryAmortizable Life
Product Acquisition Costs10 years
Trademarks and Technology15 years
Customer Relationships10 years

26

IPR&D and other related intangibles as of June 30, 2018 over the remainder of 2018 and each of the next five years is estimated to be as follows (in thousands):


 Amortization Expense *
2018 (remainder of the year)$1,550
20193,099
20203,099
20213,099
20223,099
20233,099
Thereafter18,054
Total$35,099
*IPR&D amountsProduct Acquisition costs are assessed for impairment at least annually and will be amortized over their estimated useful lives once products are approved, including the product's respective manufacturing process approvals, and are not included in the table.commercialized.
The useful lives of the Company’s intangibles are as follows:
27

Intangibles CategoryAmortizable Life
Trademarks and Technology15
Customer Relationships10
9.10. Stock-Based Compensation
 
Stock Options

The Company recognized $0.3 million and $0.6 million of compensation expense related to stock options during the three months ended June 30,March 31, 2019 and 2018, and 2017, respectively, and $0.8 million and $1.2 million during the six months ended June 30, 2018 and 2017.respectively.
The 1999 Director Stock Option Plan, as amended (the “Director Plan”), provides for the grant of stock options to non-employee directors of the Company at an exercise price equal to the fair market value per share on the date of the grant. As of December 31, 2017, an aggregate of 1,975,000 shares had been approved and authorized for issuance pursuant to the Director Plan with no change as of June 30, 2018. A total of 2,634,798 options had been granted to non-employee directors through December 31, 2017, with no change as of June 30, 2018. A total of 807,782 of those had been forfeited through December 31, 2017 and returned to the option pool for future issuance, with no change as of June 30, 2018. The options granted under the Director Plan vest in full one year after their respective grant dates and have a maximum term of ten years. As of December 31, 2017 and June 30, 2018 there were 500,000 shares of common stock options outstanding. As of December 31, 2017, the 147,984 options available were transferred to a plan that has superseded the Director Plan, as discussed further in this section, with no additional options transferred as of June 30, 2018.

The 1999 Stock Incentive Plan, as amended (“1999 Plan”), replaced all previously authorized employee stock option plans, and no additional options may be granted under those previous plans. Under the 1999 Plan, options or stock awards may be granted to all of the Company’s employees, officers, directors, consultants and advisors to purchase a maximum of 3,200,000 shares of common stock. However, pursuant to the terms of the 1999 Plan, no awards may be granted after March 16, 2009. A total of 2,892,500 options, having a maximum term of ten years, have been granted at 100% of the fair market value of the Company’s common stock at the date of grant. Options outstanding under the 1999 Plan were generally exercisable in cumulative increments over four years commencing one year from date of grant. As of June 30, 2018, there are no options outstanding under the 1999 Plan.
On June 26, 2009, the Board of Directors adopted, and the Company’s stockholders subsequently approved by written consent, the IGI Laboratories, Inc. 2009 Equity Incentive Plan (the “2009 Plan”). The 2009 Plan became effective on July 29, 2009. The 2009 Plan allows the Company to continue to grant options and restricted stock, as under the 1999 Plan, but also authorizes the Board of Directors to grant a broad range of other equity-based awards, including stock appreciation rights, restricted stock units (“RSUs”) and performance awards. The 2009 Plan has been created, pursuant to and consistent with the Company's current compensation philosophy, to assist the Company in attracting, retaining and rewarding designated employees, directors, consultants and other service providers of the Company and its subsidiaries and affiliates, in a manner that will be cost efficient to the Company from both an economic and financial accounting perspective. On April 12, 2010, the Board of Directors adopted, and the Company’s stockholders subsequently approved, an amendment and restatement of the 2009 Plan


to increase the number of shares of Common Stock available for grant under such plan by adding 2,000,000 shares of Common Stock. The 2009 Plan, as amended on May 29, 2010, authorizes up to 5,000,000 shares of the Company’s common stock for issuance pursuant to the terms of the 2009 Plan. The maximum number of shares that may be subject to awards made to any individual in any single calendar year under the 2009 Plan is 1,000,000 shares. As of June 30, 2018, there were 24,376 RSUs outstanding, 1,493,960 shares of stock outstanding, and options to purchase 2,932,846 shares of common stock outstanding. As of December 31, 2017, there were 99,626 RSUs outstanding, 1,422,020 shares of stock outstanding and options to purchase 3,038,634 shares of common stock outstanding. As of December 31, 2017, the 249,052 options available were transferred to a plan that has superseded the 2009 Plan, as discussed further in this section. As of June 30, 2018, an additional 98,098 options available were transferred to the superseded plan.


On May 25, 2016, the Board of Directors approved the Company’s 2016 Equity Incentive Plan (the “2016 Plan”). On May 21, 2018, the Board of Directors adopted, and the Company’s stockholders subsequently approved, an amendment and restatement of the 2016 Plan to increase the number of shares of Common Stock available for grant under such plan by adding 2,000,000 shares of Common Stock. The 2016 Plan, as amended, provides for the issuance of awards of up to 4,000,000 shares of the Company’s common stock, plus any shares of common stock that are represented by awards granted under our Director Plan and 2009 Plan that are forfeited, expire or are canceled without delivery of shares of common stock or which result in the forfeiture of shares of common stock back to the Company on or after May 25, 2016, up to 2,500,000 shares. Generally, shares of common stock reserved for awards under the 2016 Plan that lapse or are canceled, will be added back to the share reserve available for future awards. However, shares of common stock tendered in payment for an award or shares of common stock withheld for taxes will not be available again for grant. The 2016 Plan provides that no participant may receive awards for more than 1,000,000 shares of common stock in any fiscal year. As the 2016 Plan supersedes both the Director Plan and the 2009 Plan, any available shares from both are now incorporated into the 2016 Plan. As of June 30, 2018,March 31, 2019, there were 174,472100,773 RSUs outstanding, 49,667131,496 shares of common stock outstanding and options to purchase 1,335,529 shares of common stock outstanding under the 2016 Plan. As compared to 2017, as of December 31, 2017, there were 89,003 RSUs outstanding, 20,000 shares of common stock outstanding and options to purchase 761,1763,164,345 shares of common stock outstanding under the 2016 Plan. As of June 30,December 31, 2018, there were 161,214 RSUs outstanding, 74,667 shares of common stock outstanding and options to purchase 1,394,285 shares of common stock outstanding under the 2016 Plan. As of March 31, 2019 and December 31, 2017,2018, there were a total of 2,935,7361,363,758 shares of common stock and 1,526,8573,113,374 shares of common stock available under the 2016 Plan, respectively.
 
As of June 30, 2018March 31, 2019 and December 31, 2017,2018, there were options to purchase 4,768,1056,105,619 and 4,299,8104,352,391 shares of common stock outstanding, respectively, collectively in the Director Plan, 2009 Plan, and the 2016 Plan.


In the interest of maintaining consistency with the Company's 2016 Equity Incentive Plan, on March 13, 2017, the Company entered into (i) an amendment to the option agreements governing each option grant currently outstanding under the Company's 2009 Equity Incentive Plan, and (ii) an amendment to the RSU, agreements governing each RSU grant currently outstanding under the 2009 Plan. The amendments provide for the automatic vesting upon a change of control of the Company of each option grant and RSU grant, as applicable, outstanding under the 2009 Plan. The amendments had a de minimis value to the holders as of June 30, 2018,March 31, 2019, and therefore no additional stock compensation expense was recognized related to the amendments.


The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing formula that uses assumptions noted in the following table. Expected volatilities and risk-free interest rates are based upon the expected life of the grant.
Six months ended June 30,Three Months Ended March 31,
Assumptions2018 2017Assumptions20192018
Expected dividends—
 —
Expected dividends—  —  
Risk-free rate2.36% 1.55%Risk-free rate2.47 %2.32 %
Expected volatility60.5% - 62.3%
 58.0% - 69.7%
Expected volatility57.8%-60.2%60.5%-60.9%
Expected term (in years)3.2 - 3.3 years
 3.2 - 3.3 years
Expected term (in years)3.2-3.3 years3.2 - 3.3 years
  
Expected volatility was calculated using the historical volatility of the Company's stock over the expected life of the options. The expected life of the options was estimated based on the Company's historical data. The risk-freerisk free interest rate is based on U.S. Treasury yields for securities with terms approximating the terms of the grants. Forfeitures are recognized in the period they occur. The assumptions used in the Black-Scholes options valuation model are highly subjective, and can materially affect the resulting valuation.




A summary of option activity under the 1999 Director Stock Option Plan, the 2009 Equity Incentive Plan, and the 2016 Equity Incentive Plan as of June 30, 2018March 31, 2019 and changes during the period are presented below:

28

Number of
Options
Weighted Average
Exercise Price
Number of
Options
 
Weighted Average
Exercise Price
Outstanding as of January 1, 20184,299,810
 $5.09
Outstanding as of January 1, 2019Outstanding as of January 1, 20194,352,391 $4.61 
Issued679,785
 3.29
Issued1,866,855 1.60 
Exercised(11,000) 1.08
Exercised— — 
Forfeited(200,490) 7.02
Forfeited(113,627)4.84 
Expired—
 —
Expired— — 
Outstanding as of June 30, 20184,768,105
 $4.76
Outstanding as of March 31, 2019Outstanding as of March 31, 20196,105,619 $3.68 


  
Exercisable as of June 30, 20183,546,700
 $4.63
Exercisable as of March 31, 2019Exercisable as of March 31, 20193,601,093 $4.65 
 
The following tables summarize information regarding options outstanding and exercisable at June 30, 2018:March 31, 2019:
 
Outstanding:
Range of Exercise PricesStock Options OutstandingWeighted Average Exercise PriceWeighted Average Remaining Contractual Life
$0.79 - $1.501,652,250 $1.08 3.47
$1.51 - $5.502,642,313 2.17 9.22
$5.51 - $10.671,811,056 8.25 6.73
Total6,105,619 $3.68 6.93
Range of Exercise Prices Stock Options Outstanding Weighted Average Exercise Price Weighted Average Remaining Contractual Life
$0.55 - $1.50 1,735,000
 $1.06
 3.61
$1.51 - $5.50 873,469
 3.18
 8.52
$5.51 - $10.67 2,159,636
 8.38
 7.45
Total 4,768,105
 $4.76
 6.25




Exercisable:
Exercisable:
Range of Exercise Prices Stock Options Exercisable Weighted Average Exercise PriceRange of Exercise PricesStock Options ExercisableWeighted Average Exercise Price
$0.55 - $1.50 1,735,000
 $1.06
$0.79 - $1.50$0.79 - $1.501,510,000 $1.06 
$1.51 - $5.50 202,166
 2.75
$1.51 - $5.50452,961 3.17 
$5.51 - $10.67 1,609,534
 8.72
$5.51 - $10.671,638,132 8.36 
Total 3,546,700
 $4.63
Total3,601,093 $4.65 
 
As of June 30, 2018,March 31, 2019, the intrinsic value of the options outstanding was $4.5$0.2 million and the intrinsic value of the options exercisable was $4.3$0.2 million. As of June 30, 2018,March 31, 2019, there was $2.0$2.1 million of total unrecognized compensation expense related to non-vested share-based compensation arrangements granted under the Plan. The costs will be recognized through February 2021.March 2022.
 
Restricted Stock and RSUs
 
The Company periodically grants restricted stock and RSU awards to certain officers and other employees that typically vest one to three years from their grant date. The Company recognized $0.1 million and $0.2 million of compensation expense during the three months ended June 30,March 31, 2019 and 2018, and 2017, respectively, and $0.3 million and $0.5 during the six months ended June 30, 2018 and 2017, respectively, related to restricted stock and RSU awards.respectively. Stock compensation expense is recognized over the vesting period of the restricted stock and RSUs. At June 30, 2018,March 31, 2019, the Company had approximately $0.8$0.4 million of total unrecognized compensation cost related to non-vested restricted stock and RSUs, all of which will be recognized through April 2021.March 2022. The following table summarizes the number of unvested RSUs and their weighted average exercise price for the sixthree months ended June 30, 2018.March 31, 2019.



29

Number of RSUsWeighted Average Grant Date Fair Value
 Number of RSUs Weighted Average Exercise Price
Non-vested balance at January 1, 2018 188,629
 $8.27
Non-vested balance at January 1, 2019Non-vested balance at January 1, 2019175,591 $4.78 
Changes during the period:  
  
Changes during the period:
Shares granted 122,949
 3.36
Shares granted— — 
Shares vested (101,607) 9.07
Shares vested(71,206)5.20 
Shares forfeited (11,123) 7.21
Shares forfeited(3,612)3.53 
Non-vested balance at June 30, 2018 198,848
 $4.88
Non-vested balance at March 31, 2019Non-vested balance at March 31, 2019100,773 $4.53 


10.
30

11. Income Taxes


The Company’s income tax expense (benefit) was $0.02$0.01 million and $0.02 million for the three months ended June 30,March 31, 2019 and 2018, and 2017, respectively. For the same two periods, the effective tax rates were 0.2%0.09% and 2.6%, respectively. The Company’s income tax expense was $0.04 million and $0.1 million for the six months ended June 30, 2018 and 2017, respectively and the effective tax rates were 0.3% and 589%0.5%, respectively.


The Company conducts operations in the United States and certain foreign countries. It is the intent of the Company to permanently reinvest any earnings and profits generated by its foreign affiliates. One of its foreign affiliates is subject to tax in Estonia. Estonia has a dual tax regime: 0% tax rate for earnings and profits as they are generated and 14% to 20% tax rates for earnings and profits that are distributed to shareholders. The Company has taken the position that the 14% to 20% tax rates apply only when dividends have been declared and recognized as a liability. Accordingly, the Company has provided no taxes on the current earnings generated by its Estonian affiliate.

Income tax expense for the three and six months ended June 30, 2018 and June 30, 2017, is recognized based on the Company’s estimated annual effective tax rate, which is based on the tax rate expected for the full calendar year applied to the pre-tax income of the interim period adjusted for discrete items. The Company excludes from the calculation of the annual effective tax rate those jurisdictionsany entities that are projected to operate at a loss, and in which ahave no tax benefit will notthat can reasonably be recognized orexpected, and those entities which operate in a zero tax rate jurisdiction.

The Company has assessed the impacts of the changes resulting from Due to continuing operating losses in the United States, the tax provision is based on minimum U.S. state income taxes and the operations of certain foreign affiliates that are subject to taxes in their respective countries.

Beginning in 2018, the Company’s net interest expense became subject to limitations imposed by the Tax Cuts and Jobs Act (U.S. TCJA)of 2017 (TCJA). Based on actual and projected operating results, the Company is subject to an interest expense limitation. The limitation serves to reduce the net operating loss and create an additional attribute for the disallowed net interest expense.  Therefore, there is no effect on earnings.

Also beginning in 2018, TCJA imposed a new tax on the current earnings of controlled foreign subsidiaries called Global Intangible Low-Taxed Income (“GILTI”). The Company continues to monitor the new GLITI tax provisions, associated regulations and rulings as they are issued with the application of ASC 740, Income Taxes. The Company is allowed to make an accounting policy choice of either (1) treating taxes due on future U.S. inclusions in taxable income related to GILTI as a current-period expense when incurred (the “period cost method”) or (2) factoring such amounts into the Company's measurement of its deferred taxes (the “deferred method”). The Company's selection of an accounting policy with respect to the new GILTI tax rules will depend, in part, on analyzing its global income to determine whether it expects to have future U.S. inclusions in taxable income related to GILTI and, if so, what the impact is expected to be. Whether the Company expects to have future U.S. inclusions in taxable income related to GILTI depends not only on the Company's current structure and estimated future results of global operations, but also on its intent and ability to modify its structure. The Company is currently in the process of analyzing its structure. For 2018, the Company’s foreign entities as a whole generated an operating loss and that loss exceeds the projected foreign entities’ income for 2019. Therefore, the Company has not made any adjustments related to potential GILTI tax in its financial statements and has recognized an income tax benefit andnot yet made a corresponding receivable of $0.1 million related to the recoverability of Alternative Minimum Tax Credits. Deferred tax assets, liabilities and valuation allowances have been remeasured at the new rate of 21%. Except for the recognition of the Alternative Minimum Tax Credit, there was no income impact from the remeasurement since all U.S. net deferred tax assets are fully reserved by the Company. At present, we do not estimate any material impacts from the repatriation tax. While we have completed our provisional analysis of the income tax effects of the U.S.TCJA, the related tax effects may need to be adjusted, possibly materially, due to further refinement of our calculations, changes in interpretations and assumptions that we have made, additional guidance that may be issued by regulatory bodies, and actions and related accounting policy decision we may take as a result of the new legislation. We will complete our analysis over the one-year measurement period from the enactment of the law as provided for by "Income Tax Accounting Implications of the Tax Cuts and Jobs Act" (SAB 118), and any adjustments during this measurement period will be included in net earnings from continuing operations as an adjustmentregarding whether or not to income tax expense in the reporting period(s) when such adjustments are determined.record deferred taxes associated with GILTI.


The Company evaluates the recoverability of its net deferred tax assets based on its history of operating results, its expectations for the future and expiration dates. Based on the preponderance of the evidence, theThe Company has concluded that it is more likely than not it will be unable to realize the net deferred tax assets in the immediate future and has established a valuation allowance for all U.S. and foreign net deferred tax assets.

At December 31, 2017,2018, the Company’s U.S. federal net operating loss carryforwards totaled $41.7$45 million. The Company’s ability to use net operating loss carry forwards is subject to limitation in future periods under certain provisions of Section 382 of the Internal Revenue Code of 1986, as amended, which limit the utilization of net operating losses upon a more than 50% change in ownership of the Company’s stock that is held by 5% or greater stockholders.stock. The Company examined the application of Section 382 with respect to an ownership change that took place during 2010, as well as the limitation on the application of net operating loss carry forwards. The Company believes that net operating losses subsequent to the change date in 2010 (aggregating $23.1$26.5 million) are not subject to Section 382 limitations. The Company has estimated that the annual limitation starting in 2010 aggregates from $1.0 million to $2.3 million per year including the effect of amortization of built in gains. The Company’s net loss carryforwards may be further limited in the future if additional ownership changes occur.




The Company is subject to the provisions of ASC 740-10-25, “Income Taxes”. (ASC 740740) which prescribes a more likely-than-not threshold for the financial statement recognition of uncertain tax positions. ASC 740 clarifies the accounting for income taxes by prescribing a minimum recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. On a quarterly basis, the Company undergoes a process to evaluate whether income tax accruals are in accordance with ASC 740 guidance on uncertain tax positions. For federal purposes, post 1998 tax years remain open to examination as a result of net operating loss carryforwards. The Company is currently open to audit by the appropriate state income taxing authorities for tax years 20132014 to 2017. The Company has not recorded any liability for uncertain tax positions.
 
11.
12. Accrued Expenses


Accrued expenses represent various obligations of the Company including certain operating expenses and taxes payable.


As of June 30, 2018March 31, 2019 and December 31, 2017,2018, the largest components of accrued expenses were (in thousands):were:

31

March 31, 2019December 31, 2018
June 30, 2018 December 31, 2017
(Unaudited) (Audited)
Capital expenditures$2,476
 $1,947
Payroll1,483
 1,580
Professional fees1,284
 546
Professional fees$2,523 $2,153 
Interest expense763
 240
Interest expense2,112 1,042 
PayrollPayroll1,392 1,908 
Wholesaler feesWholesaler fees797 203 
Medicaid and MedicareMedicaid and Medicare440 383 
RoyaltiesRoyalties378 222 
RebatesRebates363 714 
Clinical studies603
 596
Clinical studies334 334 
Royalties578
 856
Medicaid and Medicare542
 1,487
Inventory and Supplies460
 58
Inventory and Supplies317 1,809 
Rebates332
 83
Capital expendituresCapital expenditures156 275 
Income Tax60
 58
Income Tax11 45 
Other688
 650
Other480 754 
$9,269
 $8,101
$9,303 $9,842 



12.
32

13. Legal and U.S. Regulatory Proceedings
 
The Company is involved from time to time in claims which arise in the ordinary course of business. In management's opinion, the Company has made adequate provision for potential liabilities, if any, arising from any such matters. However, litigation is inherently unpredictable, and the costs and other effects of pending or future litigation, governmental investigations, legal and administrative cases and proceedings (whether civil or criminal), settlements, judgments and investigations, claims and changes in any such matters, and developments or assertions by or against the Company relating to intellectual property rights and intellectual property licenses, could have a material adverse effect on its business, financial condition and operating results.

To date, twelvethirteen putative class action antitrust lawsuits have been filed against the Company along with co-defendants, including Taro Pharmaceuticals U.S.A., Inc. and Perrigo New York Inc. One “opt-out” action has additionally been filed against the Company along with thirty-four generic manufacturer co-defendants, regarding the pricing of generic econazole nitrate cream along with twenty-nine additional drug products not manufactured or sold by the Company. All actions have been consolidated by the Judicial Panel on Multidistrict Litigation to the Eastern District of Pennsylvania for pre-trial proceedings as part of the In re Generic Pharmaceuticals Pricing Antitrust Litigation matter, and the class actions have been consolidated into three actions: the direct purchaser, end payer and indirect reseller actions.

("econazole"). The class plaintiffs seek to represent nationwide or state classes consisting of persons who directly purchased, indirectly purchased, paid and/or reimbursed patients for the purchase of generic econazole from July 1, 2014 until the time the defendants’defendants' allegedly unlawful conduct ceased or will cease. The class plaintiffs seek treble damages for alleged overcharges for econazole during the alleged period of conspiracy, and certain of the class plaintiffs also seek injunctive relief against the defendants. All actions have been consolidated by the Judicial Panel on Multidistrict Litigation to the Eastern District of Pennsylvania for pre-trial proceedings as part of the In re Generic Pharmaceuticals Pricing Antitrust Litigation matter. On October 16, 2018 the court dismissed the class plaintiffs' claims against the Company with leave to replead. On December 21, 2018 the class plaintiffs filed amended complaints, which the Company moved to dismiss on February 21, 2019. This motion remains pending.


Three "opt-out" antitrust lawsuits have additionally been filed against the Company by Humana Inc.; The Kroger Co. et al.; and United HealthCare Services, Inc., and consolidated into the In re Generic Pharmaceuticals Pricing Antitrust Litigation matter by the Judicial Panel on Multidistrict Litigation. Each of the opt-out plaintiffs allege a conspiracy by thirty-five generic manufacturers to fix prices for thirtycomplaints names between thirty-six and forty-three defendants (including the Company) and involves allegations regarding the pricing of econazole along with between twenty-four and twenty-nine other drug products including econazole nitrate cream, in violation of federal antitrust laws.that were not manufactured or sold by the Company during the period at issue. The opt-out plaintiffs seek treble damages for alleged price


overcharges for the thirty drug products identified in the complaint during the alleged period of conspiracy, and two of the complaints also seek injunctive relief against the defendants.

All of these cases are in their initial stages and motionsrelief. A motion to dismiss havethe Humana Inc. and The Kroger Co., et al. opt-out complaints was filed on February 21, 2019. A motion to dismiss the United HealthCare Services, Inc. opt-out complaint has not yet been filed with respect to each of the three consolidated class actions. filed.

Due to the early stage of these cases, we are unable to form a judgment at this time as to whether an unfavorable outcome is either probable or remote or to provide an estimate of the amount or range of potential loss. We believe these cases are without merit, and we intend to vigorously defend against these claims.


On October 20, 2017, a Demand for Arbitration was filed with the American Arbitration Association by Stayma Consulting Services, Inc. (“Stayma”("Stayma") against the Company regarding the Company’sCompany's development and manufacture for Stayma of two generic drug products, one a lotion and one a cream, containing 0.05% of the active pharmaceutical ingredient flurandrenolide. The Company developed the two products and Stayma purchased commercial quantities of each; however, Stayma alleges that the Company breached agreements between the parties by developing an additional and different generic drug product, an ointment, containing flurandrenolide, and failing to meet certain contractual requirements. Stayma seeks monetary damages. Because discovery inAt this matter is ongoing,time, the Company is unable to form a judgment at this time as to whether an unfavorable outcome is either probable or remote or to provide an estimate of the amount or range of potential loss. The Company believes this case is without merit, and the Company intends to vigorously defend against these claims. The Company filed a counter-claimthree counter-claims against Stayma for its failure to pay several past due invoices of approximately $1.7 million relating to the development and commercial supply of the two subject products. These invoices have been fully reserved.products and for breaching the confidentiality provisions and exclusivity provisions of the parties' agreements.


13. Subsequent Events

The Company was unable to file its Quarterly Report on Form 10-Q for the quarter ended September 30,On December 13, 2018, with the SEC by the required filing date due to additional time required to restate the Company’s interim condensed consolidated financial statements for the three and six-months ended June 30, 2018 for the matters disclosed in Note 1. AsValdepharm SA filed a result,lawsuit alleging that the Company was notbreached contracts regarding two drug products that the Company had sought to have Valdepharm manufacture. On February 12, 2019 the Company answered the complaint and counterclaimed, alleging that Valdepharm breached the contracts by failing to perform its work in compliance with FDA regulations and current Good Manufacturing Practices. Each party seeks damages associated with the non-financial covenant prescribed byalleged breach and related claims. Due to the Term Loan disclosed in Note 7 as of September 30, 2018, which requires timely filingearly stage of the Company’s annualcase we are unable to form a judgment at this time as to whether an unfavorable outcome is either probable or remote or to provide an estimate of the amount or range of potential loss. We believe the claims against Teligent are without merit, and interim consolidated financialwe intend to vigorously defend against them.
On April 15, 2019, Mo-Kan Iron Workers Pension Fund, on behalf of itself and all other persons or entities, except defendants, who purchased Teligent common stock between May 2, 2017 and November 7, 2017, commenced a putative class action against the Company and its CEO, Jason Grenfell-Gardner, alleging violations of the securities laws. The complaint alleges that the defendants made materially misleading statements andregarding the Company’s ability to offer up to $50.0 million in debt or equity securities through its existing shelf registration statement on file with the SEC was suspended for a period of twelve months. Moreover, due to the lack ofbusiness, operational and compliance with the non-financial covenant prescribed by the Term Loan, the Company reclassified the net carrying value of $24.2 million as current debt in the accompanying Condensed Consolidated Balance Sheet as of September 30, 2018.

On November 12, 2018, the Company entered into a financing commitment whereby Ares Capital Management (“Ares”)policies. The plaintiff has agreed to loanadjourn the Company up to $120.0 million (“Ares Credit Facility”). The Ares Credit Facility will be secured by allresponse date until after the completion of the Company’s asset and will be funded in three tranches: (1) an asset based revolving credit facilitylead plaintiff appointment process under the Private Securities Litigation Reform Act of $25.0 million due November 2022 (“2022 Revolver”), (2) a term loan of $80.0 million due February 2023 (“2023 Term Loan”), and (3) a delayed draw term loan of $15.0 million also due in February 2023 (“2023 Delayed Draw Term Loan”). In addition, the Ares Credit Facility will require the Company to comply with certain affirmative non- financial covenants relating to periodic reporting and maintaining compliance with standard rules and regulations customary in the markets where the Company competes, as well as negative financial covenants limiting levels of indebtedness and restricting certain payments, as well as  minimum revenue covenants for each twelve-month period ending December 31, 2018, March 31, 2019 and June 30, 2019, minimum consolidated adjusted EBITDA covenants for the twelve-month period ending September 30, 2019, December 31, 2019, March 31, 2020, June 30, 2020 and September 30, 2020 and minimum net leverage ratio covenants for the twelve-month period ending December 31, 2020 and ending each fiscal quarter thereafter until maturity. The 2023 Term Loan and 2023 Delayed Draw Term Loan will be subordinate1995. Due to the 2022 Revolver. The proceeds from both the 2022 Revolver and 2023 Term Loan are anticipated to be funded in the fourth quarter upon executionearly stage of the final agreements with Ares, whereas the 2023 Delayed Draw Term Loan will be made available when the Company initiates capital improvementscase, we are unable to substantially increase manufacturing capacity in its Buena, New Jersey injectable manufacturing facility, whichform a judgment at this time as to whether an unfavorable outcome is currently to begin in fiscal year 2018. The Company intends to use the proceeds from 2023 Term Loan to extinguish its existing $25.0 million 2021 Term Loan, as well as extinguish its remaining outstanding $68.7 million of December 2019 Notes. The 2022 Revolver will bear interest at a rate of LIBOR plus 3.75%, whereas the 2023 Term Loan and 2023 Delayed Draw Term Loan will bear interest at a rate of LIBOR plus 8.75% with a 24-month paid-in-kind interest option available to the Company should it choose to defer cash interest payments in ordereither probable or remote or to provide further liquidityan estimate of the amount or range of potential loss. We believe the claims are without merit, and we intend to continue launching new products.vigorously defend against them.



33

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
 
This "Management's Discussion and Analysis of Financial Condition and Results of Operations" section and other sections of this Quarterly Report on Form 10-Q contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, that are based on current expectations, estimates, forecasts and projections about the industry and markets in which the Company operates and on management's beliefs and assumptions. In addition, other written or oral statements, which constitute forward-looking statements, may be made by or on behalf of the Company. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," variations of such words and similar expressions are intended to identify such forward-looking statements. These statements are based on current expectations of management and are not guarantees of future performance, and involve certain risks, uncertainties and assumptions, which are difficult to predict. These risks and uncertainties include, without limitation, competitive factors, outsourcing trends in the pharmaceutical industry, the general economic conditions in the markets in which the Company operates, levels of industry research and development spending, the Company’s ability to continue to attract and retain qualified personnel, the fixed price nature of product development agreements or the loss of customers and other factors described in the Company’s filings with the Securities and Exchange Commission, including the “Risk Factors” section as set forth in our Annual Report on Form 10-K for the year ended December 31, 2017,2018, as updated below in this Quarterly Report on Form 10-Q. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in such forward-looking statements. The forward-looking statements set forth herein speak only as of the date of this report. The Company undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by applicable law. The Company operates its business under one reportable segment.

As discussed in Note 1, Restatement of Previously Issued Unaudited Interim Condensed Consolidated Financial Statements, in the Company’s unaudited interim condensed consolidated financial statements included in Item 1 of Part I “Financial Information”, the Company’s unaudited interim condensed consolidated financial statements for the three and six-month periods ended June 30, 2018 and 2017 have been revised to give effect to the Restatement. Accordingly, the discussion and analysis below for the three and six-month periods ended June 30, 2018 and 2017 have been revised to give effect to the Restatement. The revised discussion and analysis presented below provides information to assist in understanding the Company’s financial condition and results of operations, and should be read in conjunction with the Company’s unaudited interim condensed consolidated financial statements included in Item 1.


Company Overview
 
Strategic Overview
 
Teligent, Inc. and its subsidiaries (collectively the “Company”) is a specialty generic pharmaceutical company. All references to "Teligent," the "Company," "we," "us," and "our" refer to Teligent, Inc. Our mission is to become a leader in the specialty generic pharmaceutical market. Our platform for growth is centered around the development, manufacturing and marketing a portfolio of generic pharmaceutical products in our own label in topical, injectable, complex and ophthalmic dosage forms. We believe that expanding our development and commercial base beyond topical generics, historically the cornerstone of our expertise, to include injectable generics, complex generics and ophthalmic generics (what we call our "TICO" strategy"), will leverage our existing expertise and capabilities, and broaden our platform for more diversified strategic growth.

Our pipeline includes 26 Abbreviated New Drug Applications ("ANDAs") for additional pharmaceutical products filed with the FDA. Our pipeline also includes one Prior Approval Supplement for our first opthalmic product filed in the second quarter 2017. We have three abbreviated new drug submissions ("ANDSs") on file with Health Canada. In addition, we have 39 product candidates at various stages of our development pipeline. We expect to continue to expand our presence in the generic topical pharmaceutical market through the filing of additional ANDAs with the FDA, the filing of applications to Health Canada, and the subsequent launch of products as these applications are approved. We will also seek to license or acquire further products, intellectual property, or pending applications to expand our portfolio.


We currently market and sell generic topical and generic and branded generic injectable pharmaceutical products in the United States and Canada. In the United States, we currently market 2834 generic topical pharmaceutical products and four branded generic injectable pharmaceutical products. We have received FDA approvals for 34 topical generic products from our internally developed pipeline and we have 19 Abbreviated New Drug Applications, ("ANDAs") submitted to the FDA that are awaiting approval.  In Canada, we sell over 3027 generic and branded generic injectable products and medical devices. In addition, we have 45 product candidates at various stages of our development pipeline. Generic pharmaceutical products are bioequivalent to their brand name counterparts. We also provide contract manufacturing services to the pharmaceutical, ("OTC"), and cosmetic markets. We operate our business under one segment. Our common stock is traded on the NASDAQNasdaq Global Select Market under the trading symbol “TLGT.” Our principal executive office, laboratories and manufacturing facilities are located at 105 Lincoln Avenue, Buena, New Jersey. We have additional offices located in Iselin, New Jersey, Toronto,Mississauga, Canada, and Tallinn, Estonia.
  


The manufacturing and commercialization of generic specialty pharmaceutical markets is competitive, and there are established manufacturers, suppliers and distributors actively engaged in all phases of our business. We currently manufacture and sell topical generic pharmaceutical products under our own label.


The three large wholesale drug distributors are AmerisourceBergen Corporation ("ABC"); Cardinal Health, Inc. ("Cardinal"); and McKesson Drug Company, ("McKesson"). ABC, Cardinal and McKesson are key distributors of our products, as well as a broad range of health care products for many other companies. None of these distributors is an end user of our products. Generally, if sales to any one of these distributors were to diminish or cease, we believe that the end users of our products would likely find little difficulty obtaining our products either directly from us or from another distributor. However, the loss of one or more of these distributors, together with a delay or inability to secure an alternative distribution source for end users, could have a material negative impact on our revenue, business, financial condition and results of operations. There are generally three major negotiating entities in the US market. Walgreens Boot Alliance, Inc. consists of Walgreens,
34

AmerisourceBergen's PRxO Generics program, and Econdisc members. Red Oak Sourcing consists of CVS and Cardinal’s source program. Finally, ClarusOne consists of Walmart, RiteAid and McKesson’s OneStop program. A loss of any of these major entities could result in a significant reduction in revenue.
 
We consider our business relationships with ABC, Cardinal and McKesson to be in good standing and have fee for services contracts with each of them. However, a change in purchasing patterns, a decrease in inventory levels, an increase in returns of our products, delays in purchasing products and delays in payment for products by one or more of these distributors could have a material negative impact on our revenue, business, financial condition and results of operations. We continue to analyze the market for other specialty generic drug products through internal research and development. In addition, we continue to explore business development opportunities to add additional products and/or capabilities to our existing portfolio.
 
For the three months ended June 30, 2018,March 31, 2019, we had sales to two customers, which individually accounted for 10% or more of our total revenue. Total sales to these customers represented 35%30% and 14%18%, respectively, and represented 49%48% of total revenues. Accounts receivable related to thesethe Company’s major customers comprised 33% and 16%, respectively,37% of all accounts receivable as of June 30, 2018.March 31, 2019. For the three months ended June 30, 2017,March 31, 2018, we had sales to three customers which individually accounted for more than 10% of our total revenue. Total sales to these customers represented 26%38%, 14%11% and 10%, respectively, and represented 50%59% of total revenues. Accounts receivable related to thesethe Company’s major customers comprised 67%52% of all accounts receivable as of June 30, 2017. For the six months ended June 30, 2018, we had sales to two customers, which individually accounted for more than 10% of our total revenue. Total sales to these customers represented 35% and13%, respectively, and represented 48% of total revenues. For the six months ended June 30, 2017, we had sales to three customers, which individually accounted for more than 10% of our total revenue. Total sales to these customers represented 26%, 13% and 13%, respectively, and represented 52% of total revenues.March 31, 2018.
 
Our customers in the contract manufacturing business generally consist of pharmaceutical companies, as well as cosmetic and OTC product marketers, who require product development/manufacturing support. For the three months ended June 30, 2018,March 31, 2019, approximately 69%73% of our contract manufacturing revenue was derived from pharmaceutical projects, as compared to 86%84% of total contract manufacturing revenue for the three months ended June 30, 2017. For the six months ended June 30, 2018, approximately 76% of our contract manufacturing revenue was derived from pharmaceutical projects, as compared to 85% of total contract manufacturing revenue for the six months ended June 30, 2017.March 31, 2018. None of our contract manufacturing services customers represented greater than 10% of total revenue for both the three months ended June 30, 2018March 31, 2019 and June 30, 2017. None of our contract manufacturing services customers represented greater than 10% of total revenue for both the six months ended June 30, 2018 and June 30, 2017.2018.


Product and Pipeline Approvals


The following is a summary of significant approvals received in 2018:during the three months ended March 31, 2019:


On February 14, 2018,January 2, 2019, we announced approval of an ANDA for Betamethasone Dipropionate LotionGentamicin Sulfate Ointment USP, (Augmented), 0.05%0.1%. This was our firstthirteenth approval for 2018, and our twentieththirty-second approval from ourits internally-developed pipeline of topical generic pharmaceutical medicines. We launched this product in Maythe first quarter of 2018.2019.


On March 21, 2018,January 24, 2019, we announced approval of an ANDA for HalobetasolClobetasol Propionate Ointment USP, 0.05%. This was our secondfirst approval for 20182019, and our twenty-firstthirty-third approval from ourits internally-developed pipeline of topical generic pharmaceutical medicines. We launched this product in Aprilthe first quarter of 2018.2019.


On April 6, 2018,March 14, 2019, we announced approval of an ANDA for Ciclopirox Shampoo, 1%. This was our third approval for 2018 and our twenty-second approval from our internally-developed pipeline of topical generic pharmaceutical medicines. We launched this product in May of 2018.



On April 17, 2018, we announced approval of an ANDA for Clobetasol Propionate Cream USP,Desonide ointment, 0.05%. This was our fourthsecond approval for 2018of 2019, and our twenty-thirdthirty-fourth approval from our internally-developed pipeline of topical generic pharmaceutical medicines. We launched this product in May of 2018.

On June 13, 2018, we announced approval of an ANDA for Diflorasone Diacetate Ointment, 0.05%. This was our fifth approval for 2018 and our twenty-fourth approval from ourits internally-developed pipeline of topical generic pharmaceutical medicines. We expect to launch this product in the thirdsecond quarter of 2018.2019.


On June 20, 2018,March 19, 2019, we announced approval of an ANDA for Fluocinonide GelTopical Solution USP, 0.05%. This was our sixththird approval for 2018of 2019, and our twenty-fifththirty-fifth approval from ourits internally-developed pipeline of topical generic pharmaceutical medicines. We expect to launch this product in the thirdsecond quarter of 2018.2019.

On July 2, 2018, we announced approval of an ANDA for Lidocaine and Prilocaine Cream USP, 2.5%/2.5%. This was our seventh approval for 2018 and our twenty-sixth approval from our internally-developed pipeline of topical generic pharmaceutical medicines. We expect to launch this product in the third quarter of 2018.

On July 24, 2018, we announced approval of an ANDA for Hydrocortisone Cream USP, 2.5%. This was our eighth approval for 2018 and our twenty-seventh approval from our internally-developed pipeline of topical generic pharmaceutical medicines. We expect to launch this product in the third quarter of 2018.

On July 30, 2018, we announced approval of an ANDA for Hydrocortisone Lotion USP, 2.5%. This was our ninth approval for 2018 and our twenty-eighth approval from our internally-developed pipeline of topical generic pharmaceutical medicines. We expect to launch this product in the third quarter of 2018.

Out of Period Adjustments

For the three and six months ended June 30, 2018, the Company recorded the following adjustments (in thousands) related to prior periods. The net impact of the adjustments on any prior annual or interim periods financial statements was not significant. There were no adjustments related to prior periods recorded for the three and six months ended June 30, 2017.



Three months ended
Six months ended


June 30, 2018
June 30, 2018
Wholesale fees (Revenue)
$856

$1,218
Medicaid (Revenue)
297

297
Pricing and shipment adjustment (Revenue)
(502)
(502)
Sales return reserve (Revenue)
—

(577)
Inventory adjustments (Cost of revenues)
—

95
Capitalization of property, plant and equipment (Cost of revenues)
263

263
Bad debt expense (Selling, general and administrative expenses)
(578)
(578)


$336

$216


Results of Operations

Three months ended June 30, 2018March 31, 2019 compared to June 30, 2017March 31, 2018
 
We had a net loss of $13.1$8.7 million, or $0.25$0.16 per share, for the three months ended June 30, 2018,March 31, 2019 ("Current Period"), compared to a net loss of $0.9$4.8 million, or $0.02$0.09 per share, for the three months ended June 30, 2017.March 31, 2018 ("Prior Period").  Product Sales, net, include Company Product Sales and Contract Manufacturing Sales, as follows:




Revenues (in thousands):
35

  Three Months Ended June 30, Increase/(Decrease)
Components of Revenue: 2018 2017 $ %
Product sales, net $16,127
 $16,319
 $(192) (1)%
Research and development services and other income 122
 113
 9
 8 %
Total Revenues $16,249
 $16,432
 $(183) (1)%
Revenues:

Three Months Ended March 31,Increase/(Decrease)
Components of Revenue:20192018$%
Product sales, net$13,037 $14,534 $(1,497)(10)%
Research and development services and other income85 11 74 673 %
Total Revenues$13,122 $14,545 $(1,423)(10)%
Revenues were $16.2
Total revenues decreased by 10% to $13.1 million for the three months ended June 30, 2018, compared to $16.4Current Period from $14.5 million forfrom the same period in the prior year. This represents a $0.2Prior Period. The $1.4 million decrease primarily resulted from a decline in 2018 from the same periodour contract manufacturing revenues of $0.7 million and a decline in the prior year. This decrease inour own generic pharmaceutical product sales of $0.2$0.7 million is attributedas we proactively discontinued unprofitable contracts in order to a decreaseoptimize the commercial viability of our in-line product portfolio in revenue from Zantac Injectable which represented 8% of total revenue in the second quarter of 2017, as comparedorder to 7% of total revenue in the second quarter of 2018, Lidocaine Ointment which represented 23% of total revenue in the second quarter of 2017, as compared to 6% of total revenue in the second quarter of 2018 and contract manufacturing services revenue decreased quarter over quarter, from 15% of total revenue down to 9%. This was partially offset by the product launch of Hydrocortisone Butyrate Lotion. increase gross margin.

Research and development services and other income will not be consistent and will vary, from period to period, depending on the required timeline of each development project and/or agreement.


Costs and Expenses (in thousands):Expenses:
Three Months Ended March 31,Increase/(Decrease)
20192018$%
Cost of revenues$7,360 $9,325 $(1,965)(21)%
Selling, general and administrative expenses5,513 5,360 153 3 %
Product development and research expenses2,989 3,391 (402)(12)%
Totals costs and expenditures$15,862 $18,076 $(2,214)(12)%
  Three Months Ended June 30, Increase/(Decrease)
  2018 2017 $ %
Cost of revenues $11,465
 $8,395
 $3,070
 37 %
Selling, general and administrative expenses 5,727
 4,706
 1,021
 22 %
Product development and research expenses 3,967
 5,113
 (1,146) (22)%
Totals costs and expenditures $21,159
 $18,214
 $2,945
 16 %


Cost of revenues increased as a percentage of total revenuedecreased by 21% to 71%$7.4 million for the three months ended June 30, 2018 as comparedCurrent Period from $9.3 million from the Prior Period. Gross margin increased to 51% for44% in the same period in 2017. The increase in costCurrent Period from 36% from the Prior Period which supports our effort to optimize our product portfolio and improve our product profitability from the second half of sales as a percentage of revenue was driven by new product launches as well as changes in product mix and pricing, in addition to customer and product mix for our contract services revenue.  For the three months ended June 30, 2018, cost2018. Cost of revenues also included an increasedecreased $2.0 million in inventory reserves of $0.5 million of costs related to the write-down of inventory. Some production inefficiencies can be attributed to the expanding of our manufacturing footprint and capacityCurrent Year mainly resulted from decrease in topical manufacturing, and adding sterile manufacturing capabilities at the existing facility.      sales volume.


Selling, general and administrative expenses forin the three months ended June 30, 2018Current Period increased by $1.0$0.2 million as compared to the same periodPrior Period. This change was due to an increase in 2017. For the three months ended June 30, 2018 there were increasesprofessional fees of $0.6$0.8 million forpartially offset by a reduction in personnel costs of $0.4 million and a decline in bad debt expense $0.5 million increase in legal and professional fees offset by a $0.1 million decrease in salaries and related costs.of $0.2 million.

Product development and research expenses for the three months ended June 30, 2018 decreased by approximately $1.1$0.4 million as compared to the same period in 2017.Prior period. The decrease in product development and research expenses was primarily due to a(i) $0.2 million decrease in clinical studies of $1.1 million and related testing of $0.4 million offset by an increase in GDUFA fees, of(ii) $0.3 million decrease in personnel costs and anpartially offset by $0.2 million increase in business insurance of $0.1 million.clinical studies.


Other Expense (in thousands):(Expense) Income, net:
Three Months Ended March 31,(Increase)/Decrease
20192018$%
Interest and other expense, net$(4,947)$(2,572)$(2,375)(92)%
Foreign currency exchange (loss) / gain(844)1,325 (2,169)(164)%
Debt partial extinguishment of 2019 Notes(185)— (185)— %
  Three Months Ended June 30, (Increase)/Decrease
  2018 2017 $ %
Debt partial extinguishment of 2019 Notes $(2,467) $—
 $(2,467) — %
Interest and other expense, net $(2,499) $(2,936) $437
 15 %
Foreign currency exchange (loss) gain $(3,220) $3,822
 $(7,042) (184)%


As discussed in Note 7Interest and other expense, net increased in the Unaudited Condensed Consolidated Financial Statements included in Item 1Current Period primarily as a result of Part 1 "Financial Information", on April 27, 2018, the Company entered into separate exchange agreements with certain holders of the 2019 Notes. There was a $75.1 million exchange of the 2019 Notes for 2023 Notes, which is considered a partial extinguishment, and which


resulted in the acceleration of $2.5 million of non-cash interest expense in the quarter ended June 30, 2018. Interest expense decreased by $0.4 million for the three months ended June 30, 2018 as compared to the same period in 2017. The decrease is related to the increase in capitalized interest, from $0.7 million for the three months ended June 30, 2017 to $1.5 million for the three months ended June 30, 2018 (related to our facility expansion), offset by a slightan increase in interest expense amortization of $1.0 million related to the current debt discountstructure and amortizationa decrease in capitalized interest of debt issuance costs of$1.3 million from Prior Period pertaining to the new debt. A foreignBuena facility.

Foreign exchange loss of $3.2$0.8 million was recorded in the three months ended June 30, 2018, primarilyCurrent Period was related to the foreign currency translation of our intercompany loans denominated in U.S. dollars to our foreign subsidiaries.subsidiaries to be repaid in November 2022. Depending on the changes in
36

foreign currency exchange rates, we will continue to record a non-cash gain or loss on translation for the remainder of theremaining term of these loans. Due to the nature of this transaction, there is no economic benefit to the Company to hedge this transaction.
 
Net Lossloss attributable to common stockholders (in thousands, except per share numbers):

Three Months Ended June 30, Increase/(Decrease)Three Months Ended March 31,Increase/(Decrease)
2018 2017 $ %20192018$%
Net loss attributable to common stockholders$(13,119) $(919) $(12,200) (1,328)%Net loss attributable to common stockholders$(8,724)$(4,802)$3,922 82 %
Basic and diluted loss per share$(0.25) $(0.02) $(0.23) (1,150)%Basic and diluted loss per share$(0.16)$(0.09)$0.07 78 %

Net loss for the three months ended June 30, 2018Current Period was $13.1$8.7 million as compared to $0.9net loss of $4.8 million infor the same period last year.Prior Period. The increase in loss iswas primarily due to an increase in costs and expenses in 2018 of $2.9 million, an increase in debt partial extinguishment of 2019 Notes of $2.5 million, a decrease in interest and other expenseexpenses of $0.4 million; and an increase in the foreign currency exchange loss of $7.0 million.


Six months ended June 30, 2018 compared to June 30, 2017

We had net loss of $17.9$2.4 million, or $0.34 per share, for the six months ended June 30, 2018, compared to a net loss of $0.1 million, or $0.00 per share, for the six months ended June 30, 2017, which resulted from the following:

Revenues (in thousands):
  Six Months Ended June 30, Increase/(Decrease)
Components of Revenue: 2018 2017 $ %
Product sales, net $30,661
 $33,944
 $(3,283) (10)%
Research and development services and other income 133
 151
 (18) (12)%
Total Revenues $30,794
 $34,095
 $(3,301) (10)%

Revenues were $30.8 million for the six months ended June 30, 2018, compared to $34.1 million for the same period in the prior year. This represents a $3.3 million decrease in 2018 from the same period in the prior year. This decrease in product sales of $3.3 million is attributed to a decrease in revenue from Zantac Injectable which represented 13% of total revenue for the six months ended June 30, 2017, as compared to 7% of total revenue for the six months ended June 30, 2018, Lidocaine Ointment which represented 20% of total revenue for the six months ended June 30, 2017, as compared to 6% of total revenue for the six months ended June 30, 2018 and contract manufacturing services revenue decreased year over year, from 17% of total revenue down to 9%. This was partially offset by the product launch of Hydrocortisone Butyrate Lotion. 

Research and development services and other income will not be consistent and will vary, from period to period, depending on the required timeline of each development project and/or agreement.

Costs and Expenses (in thousands):



  Six Months Ended June 30, Increase/(Decrease)
  2018 2017 $ %
Cost of revenues $20,790
 $15,124
 $5,666
 37 %
Selling, general and administrative expenses 11,087
 9,005
 2,082
 23 %
Product development and research expenses 7,358
 8,781
 (1,423) (16)%
Totals costs and expenditures $39,235
 $32,910
 $6,325
 19 %

Cost of revenues increased as a percentage of total revenue to 68% for the six months ended June 30, 2018 as compared to 44% for the same period in 2017. The increase in cost of sales as a percentage of revenue was driven by new product launches as well as changes in product mix and pricing, in addition to customer and product mix for our contract services revenue. For the six months ended June 30, 2018, cost of revenues also included an increase in inventory reserves of $1.4 million of costs related to inventory and raw materials that were expected to expire in less than six months, and other costs. Some production inefficiencies can be attributed to the expanding of our manufacturing footprint and capacity in topical manufacturing, and adding sterile manufacturing capabilities at the existing facility.     

Selling, general and administrative expenses for the six months ended June 30, 2018 increased by $2.1 million as compared to the same period in 2017. For the six months ended June 30, 2018 there were increases of $1.1 million in legal and professional fees, $0.6 million in bad debt expense, $0.7 million in salaries and related costs, primarily driven by a one time payment of $0.2 million (see Exhibit 33.1), offset by a decrease of $0.5 million in stock based compensation related to options and restricted stock.
Product development and research expenses for the six months ended June 30, 2018 decreased by approximately $1.4 million as compared to the same period in 2017. The decrease in product development and research expenses was primarily due to a decrease in clinical studies of $1.4 million and related testing of $0.5 million offset by an increase in GDUFA fees of $0.3 million and an increase in business insurance of $0.2 million, due to an increase in headcount.

Other Expense (in thousands):

  Six Months Ended June 30, (Increase)/Decrease
  2018 2017 $ %
Debt partial extinguishment of 2019 Notes $(2,467) $—
 $(2,467) — %
Interest and other expense, net $(5,071) $(6,068) $997
 16 %
Foreign currency exchange (loss) gain $(1,895) $4,901
 $(6,796) (139)%

As discussed in Note 7 in the Unaudited Condensed Consolidated Financial Statements included in Item 1 of Part 1 "Financial Information", on April 27, 2018, the Company entered into separate exchange agreements with certain holders of the 2019 Notes. There was a $75.1 million exchange of the 2019 Notes for 2023 Notes, which is considered a partial extinguishment, and which resulted in the acceleration of $2.5 million of non-cash interest expense for the six months ended June 30, 2018. Interest expense decreased by $1.0 million for the six months ended June 30, 2018 as compared to the same period in 2017. The decrease is related to the increase in capitalized interest, from $1.2 million for the six months ended June 30, 2017 to $2.8 million for the six months ended June 30, 2018 (related to our facility expansion), offset by an increase in interest expense, amortization of debt discount and amortization of debt issuance costs of the new debt. A foreign exchange loss of $1.9$2.2 million, was recorded in the six months ended June 30, 2018, as compared todebt extinguishment losses of $0.2 million, partially offset by a $4.9 million foreign exchange gain, recorded in the six months ended June 30, 2017, primarily related to the foreign currency translation of our intercompany loans denominated in U.S. dollars to our foreign subsidiaries. Depending on the changes in foreign currency exchange rates, we will continue to record a non-cash gain or loss on translation for the remainder of the term of these loans. Due to the nature of this transaction, there is no economic benefit to the Company to hedge this transaction.

Net Loss (in thousands, except per share numbers):


  Six Months Ended June 30, Increase/(Decrease)
  2018 2017 $ %
Net loss attributable to common stockholders $(17,921) $(88) $(18,009) —%
Basic and diluted loss per share $(0.34) $0.00
 $(0.34) —%

Net loss for the six months ended June 30, 2018 was $17.9 million as compared to $0.1 million in the same period last year. The increase in loss is due to a decrease in revenue of $3.3 million and increasesdecline in costs and expenses in 2018 of $6.3 million, an increase in debt partial extinguishment of 2019 Notes of $2.5 million, a decrease in interest and other expense of $1.0$2.2 million and an increasea decline in revenues of $1.4 million in the foreign currency exchange loss of $6.8 million,Current Period as noteddiscussed above.

Liquidity and Capital Resources
 
Our cash flows from operating, investing and financing activities, as reflected in the condensed Consolidated Statements of Cash Flows, are summarized in the following table (in thousands):table:
Three months ended March 31,
20192018
Net cash provided by (used in)
Operating Activities$(6,051)$(9,549)
Investing Activities$(2,129)$(4,094)
Financing Activities$2,202 $— 
 Six Months Ended June 30,
 2018 2017
Net cash provided by (used in) 
  
Operating Activities$(12,510) $(1,307)
Investing Activities$(12,523) $(15,286)
Financing Activities$12,555
 $267
Operating Activities
 
Our operating activities used $12.5$6.1 million and $9.5 million of cash and cash equivalents in the sixthree months ended June 30,March 31, 2019 and 2018, comparedrespectively, mainly to $1.3support our operational activities, which includes a $5.1 million used during the same period last year. The cash usedbuild in operating activities for the six months ended June 30, 2018 was a result of our net loss, adjusted for $15.1 million of non-cash expenses offset by a $9.7 million changeinventory and normal timing differences in operating assets and liabilities. The change is related to a significant decrease in accounts payable and accrued expenses resulting from payments made towards our manufacturing expansion project. The cash used in operating activities for the six months ended June 30, 2017 was a result of our net loss, adjusted for $4.6 million of non-cash expenses offset by a $5.8 million change in operating assets and liabilities.working capital balances.


Investing Activities
 
Our investing activities used $12.5 million during the six months ended June 30, 2018, compared to $15.3$2.1 million of cash and equivalents during the three months ended March 31, 2019, compared to $4.1 million used in investing activities during the same period last year. The funds used for both periods were for capital expenditures, mainlyyear, which was primarily related to the ongoingwith our facility expansion locatedproject in Buena, New Jersey. The decrease duringNJ. We received certification of completion of our expanded facility in the six months ended June 30,fourth quarter of 2018 is dueand continued to develop and file further regulatory submissions with the timing of payments directly related to our manufacturing expansion project.FDA in 2019.


Financing Activities
 
Our financing activities provided $12.6$2.2 million of cash and cash equivalents during the three months ended March 31, 2019. Our financing activities neither provided nor used cash during the sixthree months ended June 30, 2018, compared to $0.3 million ofMarch 31, 2018. The cash provided during the sixthree months ended June 30, 2017. In the six months ended June 30, 2018, $15.0March 31, 2019 consisted of $5.0 million was borrowed from the 2021 Term Loan, while $2.5 million was used to pay costs associated with the 2023 Notes and 2021 Term Loan. The $0.3 million of cash provided in the six months ended June 30, 2017 consisted of proceeds from the exerciseRevolver offset by $2.7 million used to repurchase a portion of options to purchase common stock.the remaining 2019 Notes.
 
Our principal sourcescapital resources were comprised of liquidity are cash and cash equivalents of approximately $13.7$6.4 million and $9.7 million as of March 31, 2019 and December 31, 2018 respectively.  We had working capital of $14.4 million at June 30, 2018March 31, 2019 and future cash from operations. Our working capital was $31.5$15.8 million at June 30, 2018.December 31, 2018 respectively.


In order to continue normal business operations and execution of the Company’s growth strategy, the Company will need tomay exercise its ability to significantly defer or reduce planned discretionary investments in research and development and capital projects or seek other financing alternatives. Other financing alternatives may include raising additional capital through the sale of its equity, a strategic alliance with a third party or securing debt. If additional acquisition and growth opportunities arise, external financing will be required. On May 4, 2018, the Company filed Form S-3 under the Securities Act of 1933. The S-3 registration allows the Company to issue, from time to time and at prices to be determined at or prior to the offering, up to $50.0 million of any combination of the securities described in the prospectus, either individually or in units should the need to raise cash arise.



37
On June 1, 2018, the Company entered into a credit agreement for $25.0 million, due June 1, 2021 ('2021 Term Loan") to support the operations of the business. The first $15.0 million of loan proceeds was received on June 1, 2018. The remaining loan proceeds of $10.0 million was received on July 16, 2018.


The Company still has a portion of convertible senior notes (“2019 Notes”) due December 2019. The Company is currently evaluating alternative financing methods to assist with repayment of the 2019 Notes in addition to continued financing of major projects including the manufacturing facility in Buena. As the Company continues to review its capital and debt structure, there can be no assurance that a strategic alliance or debt financing will be available on terms acceptable to the Company, or at all. The board of directors and management of the Company intend to exhaust all options available in order to enable the Company to support its current growth strategy and operations beyond December 2019.

The Company was unable to file its Quarterly Report on Form 10-Q for the quarter ended September 30, 2018 with the SEC by the required filing date due to additional time required to restate the Company’s interim condensed consolidated financial statements for the three and six-months ended June 30, 2018 for the matters disclosed in Note 1. As a result, the Company was not in compliance with the non-financial covenant prescribed by the Term Loan disclosed in Note 7 as of September 30, 2018, which requires timely filing of the Company’s annual and interim consolidated financial statements, and the Company’s ability to offer up to $50.0 million in debt or equity securities through its existing shelf registration statement on file with the SEC was suspended for a period of twelve months. Moreover, due to the lack of compliance with the non-financial covenant prescribed by the Term Loan, the Company reclassified the net carrying value of $24.2 million as current debt in the accompanying Condensed Consolidated Balance Sheet as of September 30, 2018.

On November 12, 2018, the Company entered intosecured a financing commitment whereby Ares Capital Management (“Ares”) has agreed to loan the Company up to $120 million (“Ares Credit Facility”).credit agreement for $120.0 million. The Ares Credit Facility will be secured by allfacility includes three tranches of the Company’s asset and will be funded in three tranches: (1)funding, an asset based revolving credit facility of $25.0 million due November 2022 (“2022 Revolver”), (2) a term loan of $80.0 million due February 2023 (“2023 Term Loan”), and (3) a delayed draw term loan of $15.0 million also due in February 2023 (“2023 Delayed Draw Term Loan”). In addition,

The interest rate under the Ares Credit Facility will requireRevolver is calculated, at the option of the Company, to comply with certain affirmative non- financial covenants relating to periodic reporting and maintaining compliance with standard rules and regulations customary inat either the markets whereone, two, three or six-month LIBOR plus 3.75% or the Company competes, as well as negative financial covenants limiting levels of indebtedness and restricting certain payments, as well as  minimum revenue covenants for each twelve-month period ending December 31, 2018, March 31, 2019 and June 30, 2019, minimum consolidated adjusted EBITDA covenants forbase rate plus 2.75%. The interest rate on the twelve-month period ending September 30, 2019, December 31, 2019, March 31, 2020, June 30, 2020 and September 30, 2020 and minimum net leverage ratio covenants for the twelve-month period ending December 31, 2020 and ending each fiscal quarter thereafter until maturity. The 2023 Term Loan and 2023 Delayed Draw Term Loan will be subordinate to the 2022 Revolver. The proceeds from both the 2022 Revolver and 2023 Term Loan are anticipated to be funded in the fourth quarter upon execution of the final agreements with Ares, whereas the 2023 Delayed Draw Term Loan will be made available when the Company initiates capital improvements to substantially increase manufacturing capacity in its Buena, New Jersey injectable manufacturing facility, which is currently scheduled to begin in fiscal year 2019. The Company intends to use the proceeds from 2023 Term Loan to extinguish its existing $25.0 million 2021 Term Loan, as well as extinguish its remaining outstanding $68.7 million of December 2019 Notes. The 2022 Revolver will bear interest, at a ratethe option of the Company, at either the one, two, three or six-month LIBOR plus 3.75%, whereas8.75% or the 2023 Term Loan and 2023 Delayed Draw Term Loan will bear interest at abase rate of LIBOR plus 8.75%7.75%, with a 24-month paid-in-kind interest option available to the Company should it choose to defer cash interest payments in order to provide furthermaintain the liquidity needed to continue launching new products.products, build inventory, and prepare for the FDA prior approval inspection.  As of March 31, 2019, the Company elected the paid-in-kind interest option and increased the principal balance of 2023 Term Loan by $2.0 million to $72.0 million.


Off Balance Sheet Arrangements
 
We have no significant off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to our shareholders.


Critical Accounting Policies and Estimates
 
Our condensed consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles, which require management to make estimates and assumptions about future events that affect the amounts reported in the financial statements and the accompanying notes. Actual results could differ from these estimates.
 
Please refer to our Annual Report on Form 10-K for the year ended December 31, 20172018 for a complete list of all Critical Accounting Policies and Estimates. See also Item 1 for our Condensed Consolidated Financial Statements.
 

ITEM 3. Quantitative and Qualitative Disclosures About Market Risk


 
As of June 30, 2018,March 31, 2019, our principal debt obligation was related to our 2019 and 2023 Notes.Notes and New Senior Credit Facilities. Interest accrues at a fixed rate of 3.75% on the outstanding principal amount of the 2019 Notes and is paid semi-annually every June 15 and December 15 until the 2019 Notes mature on December 15, 2019.  Interest accrues at a fixed rate of 4.75% on the outstanding principal amount of the 2023 Notes and is paid semi-annually every May 1 and November 1 until the 2023 Notes mature on May 1, 2023.  Since the interest rate is fixed, we have no market risk related to the 2019 and 2023 Notes.

Additionally, on June 1,On December 13, 2018, pursuant to a Commitment Letter, dated November 12, 2018, between us and Ares Management LLC, we entered into: (i) a First Lien Revolving Credit Agreement, by and among us, as the borrower, certain subsidiaries of the ours, as guarantors, the lenders from time to time party thereto, and ACF Finco I LP, as administrative agent (the “Revolver Credit Agreement”) and (ii) a Second Lien Credit Agreement, by and among the Company, entered into aas the borrower, certain subsidiaries of the Company, as guarantors, the lenders from time to time party thereto, and Ares Capital Corporation, as administrative agent (the “Second Lien Credit Agreement” and, together with the Revolver Credit Agreement, the “New Senior Credit Facilities”).

The New Senior Credit Facilities consist of an asset based revolving credit agreement forfacility of $25.0 million secured by all Company assets, due June 1, 2021November 2022 ("Revolver"), a term loan of $80.0 million due February 2023 (“20212023 Term Loan”), and a delayed draw term loan of $15.0 million also due in February 2023 (“2023 Delayed Draw Term Loan”). The first $15.0 millioninterest rate under the Revolver is calculated, at the option of loan proceeds was receivedthe Company, at either the one, two, three or six-month LIBOR plus 3.75% or the base rate plus 2.75%. The interest rate on June 1, 2018. The remaining loan proceeds of $10.0 million was received on July 16, 2018. The 2021the 2023 Term Loan bearsand 2023 Delayed Draw Term Loan bear interest, at a ratethe option of the Company, at either the one, two, three or six-month LIBOR plus 9%8.75% or the base rate plus 7.75%, and is thereforewith a 24-month paid-in-kind interest option available to us should the Company choose to defer cash payments in order to maintain the liquidity needed to continue launching new products. All three tranches of funding are subject to market risk.

Our financial instruments include cash and cash equivalents, accounts receivable, accounts payable and the Notes. The fair values of cash and cash equivalents, accounts receivable and accounts payable approximate book value because of the short maturity of these instruments.  BasedAs of March 31, 2019, based on the closing price of our common stock as of June 30, 2018,level 2 inputs, the fair value of our Notes (2019 Notes and 2023 Notes) was approximately $115.7$64.3 million compared to their facecarrying value of $143.75 million$69.9 million.  For description of the fair value hierarchy and the Company's fair value methodologies, see Note 2 " Summary of Significant Accounting Policies". In addition, the value
38

of our Senior Credit Facilities was stated at carrying value at March 31, 2019. The Company believes it could obtain borrowings at March 31, 2019 with comparable terms as of June 30, 2018.  However, this variance is due to the conversion feature inDecember 13, 2018 Senior Credit Facilities, therefore, the Notes rather than to changes in market interest rates.  As noted above, the Notes carry a fixed interest rate and therefore do not subject us to interest rate risk.carrying value approximates fair value.


At June 30, 2018,March 31, 2019, the majority of our cash and cash equivalents was invested in overnight instruments, the interest rates of which may change daily.  Accordingly, these overnight investments are subject to market risk.
 
ITEM 4. Controls and Procedures


Evaluation of Disclosure Controls and Procedures
 
Based onIn connection with the filing of this Form 10-Q for the quarter ended March 31, 2019, our Chief Executive Officer ("CEO") and our Chief Financial Officer ("CFO") conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) under the Securities Exchange Act of 1934) required by Rules 13a-15(b) or 15d-15(b) under the Securities Exchange Act of 1934, as amended (“Exchange Act”)). As a result of this evaluation, our Chief Executive OfficerCEO and our Chief Financial Officer haveCFO concluded that the Company has not maintained effective controls due tothose material weaknesses previously identified in internal control over financial reporting described in Part II, Item 9A9A. “Controls and Procedures” of our 2017Annual Report on Form 10-K for the year ended December 31, 2017 and a summary2018 were still present as of suchMarch 31, 2019 (“the Evaluation Date”). Based on those material weaknesses, isand the evaluation of our disclosure controls and procedures, our CEO and CFO concluded that our disclosure controls and procedures were not effective as follows:

Control Environment

We did not maintain an effective control environment based on the criteria established in the Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“the COSO framework”). We have identified deficiencies in the principles associated with the control environment of the COSO framework. Specifically, these control deficiencies constitute material weaknesses, either individually or in the aggregate, relating to: (i) appropriate organizational structure, reporting lines, and authority and responsibilities in pursuit of objectives, (ii) our commitment to attract, develop, and retain competent individuals, and (iii) holding individuals accountable for their internal control related responsibilities. As disclosed in the condensed consolidated financial statements included in Item 1. “Financial Statements”, these material weaknesses resulted in accounting errors.Evaluation Date.

We did not maintain an effective control environment to enable the identification and mitigation of risks of accounting errors based on the contributing factors to material weakness in the control environment, including:

We did not attract, develop, and retain competent management, accounting, financial reporting, internal audit, and information systems personnel or resources to ensure that internal control responsibilities were performed and that information systems were aligned with internal control objectives.

Our oversight processes and procedures that guide individuals in applying internal control over financial reporting were not adequate in preventing or detecting accounting errors.

Control Activities

We did not design and implement effective control activities based on the criteria established in the COSO framework. We have identified deficiencies in the principles associated with the control activities component of the COSO framework. Specifically, these control deficiencies constitute material weaknesses, either individually or in the aggregate, relating to: (i) selecting and developing control activities and information technology that contribute to the mitigation of risks and support achievement of


objectives and (ii) deploying control activities through policies that establish what is expected and procedures that put policies into action.

The following deficiencies in control activities, among others, contributed to accounting errors or the potential for there to have been accounting errors in substantially all financial statements account balances and disclosures:

Lack of sufficient technical expertise within the accounting and financial reporting department as it relates to accounting for non-recurring complex debt transactions; and
Ineffective controls over the application of accounting guidance in prior years related to the accounting for wholesaler fees, Medicaid and Medicare payments, and other rebates as well as improper disclosure related to the accounting for these fees upon adoption of FASB ASC 606, Revenue from Contracts with Customers, in the first quarter of fiscal year 2018;
Ineffective controls over price concessions in Canada specifically, we have inadequate controls to ensure that the information necessary to properly record transactions is adequately communicated on a timely basis from non-financial personnel to those responsible for accounting and financial reporting;
Ineffective controls over the application of accounting guidance and the Company’s policy related to the allowance for doubtful accounts;
Ineffective controls over the transition and implementation of the new accounting standard related to revenue recognition in the first quarter of 2018.

Information and Communication

We did not generate and provide quality information and communication based on the criteria established in the COSO framework. We have identified deficiencies in the principles associated with the information and communication component of the COSO framework. Specifically, these control deficiencies constitute material weaknesses, either individually or in the aggregate, relating to: (i) obtaining, generating, and using relevant quality information to support the function of internal control, (ii) communicating accurate information internally and externally, including providing information pursuant to objectives, responsibilities, and functions of internal control, and (iii) the monitoring of the design and operating effectiveness of controls related to the Company’s key ERP third party service provider.

Notwithstanding the identified material weaknesses, management believes that the unaudited condensed consolidated financial statements included in this Form 10-Q fairly present in all material respects our financial condition, results of operations, and cash flows as of June 30, 2018. 


Changes in Internal Control Overover Financial Reporting


Except for the previously disclosed material weaknesses described above, thereThere were no changes during the quarter ended March 31, 2019 in our internal control over financial reporting during the second quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Accounting errors corrected in the quarter were systemic to the material weaknesses previously identified by the Company.


Remediation Plan and Status


Our remediation efforts previously identified in Item 9A. “Controls and Procedures” of our Annual Report on Form 10-K for the year ended December 31, 2018 are ongoing and we will continue our initiatives to implement and document policies, procedures, and internal controls. Remediation of the identified material weaknesses and strengthening our internal control environment will require a substantial effort throughout 2019 and beyond, as necessary. We will test the ongoing operating effectiveness of thecertain new and existing controls in future periods. Theconnection with our annual evaluation of the effectiveness of internal control over financial reporting; however, the material weaknesses cannot be considered completely remediated until the applicable controls have operated for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively.

While we believe the steps taken to date and those planned for implementation will improve the effectiveness of our internal control over financial reporting, we have not completed all remediation efforts identified herein.efforts. Accordingly, as we continue to monitor the effectiveness of our internal control over financial reporting in the areas affected by the material weaknesses, described above, we have and will continue to perform additional procedures prescribed by management, including the use of manual mitigating control procedures and employing any additional tools and resources deemed necessary, to ensure that our consolidated financial statements are fairly stated in all material respects. The followingplanned remediation activities described in Item 9A. “Controls and Procedures” of our Annual Report on Form 10-K for the year ended December 31, 2018 highlight our commitment to remediating our identified material weaknesses:
Control Environment



We have undertaken certain steps to address material weaknesses in the control environment. Management team changes, including our Chief Financial Officer and Controller, are committed to implementing and maintaining an effective control environment that will drive a high level of integrity over internal control over financial reporting. Our Audit Committee and management have emphasized and continue to emphasize the importance of internal control over financial reporting, as well as the integrity of our financial statements.

Executive management has taken, and will continue to take, steps to ensure that previously identified control deficiencies will be remediatedremain largely unchanged through the implementationdate of uniform accounting and internal control policies and procedures with the proper oversight that promotes compliance with GAAP and regulatory requirements.filing this Quarterly Report on Form 10-Q.”


We will hire new finance team members with the appropriate experience, certifications, education, and training for key financial reporting and accounting positions. To date, we hired a new senior leader in one of our foreign affiliates who, among other responsibilities, ensures customer contract terms and price concessions are reviewed with key members of the accounting and financial reporting department on a timely basis to appropriately reflect in the financial records. In addition, we hired new accounting and financial reporting team members and engaged external resources with significant experience with systems similar to the Company's ERP system and infrastructure to provide additional capacity, analytical and functional capabilities, and cross-training. The addition of skilled personnel will allow us to select and develop appropriate policies, procedures, and controls to strengthen our control environment.

Executive management will continue to evaluate the need for additional resources within our accounting and financial reporting, internal audit, and information technology functions. They will also continue to evaluate the effectiveness of these personnel and appropriateness of reporting lines across the company.

Control Activities

We have begun the process of redesigning and implementing internal control activities. We also plan to establish accounting and internal audit policies and procedures and enhance oversight over process-level controls and structures to ensure that there is appropriate assignment of authority, responsibility, and accountability to enable remediating our material weaknesses.

Information and Communication

We have taken various steps to enhance our practices as it relates to information and communication, including conducting periodic reviews of the ERP system access to ensure appropriate segregation of duties exists for functional and administrative users and establishing policies and procedures addressing the internal control framework and operating effectiveness of the Company’s third-party ERP service provider.
PART II
OTHER INFORMATION
 
ITEM 1. Legal Proceedings

We are involved from timeInformation about the legal proceedings is included in Item 1, Notes to time in claims which arise in the ordinary courseunaudited Condensed Consolidated Financial Statements of business. In the opinion of management, we have made adequate provision for potential liabilities, if any, arising from any such matters. However, litigation is inherently unpredictable, and the costs and other effects of pending or future litigation, governmental investigations, legal and administrative cases and proceedings (whether civil or criminal), settlements, judgments and investigations, claims and changes in any such matters, and developments or assertions by or against us relating to intellectual property rights and intellectual property licenses, could have a material adverse effect on our business, financial condition and operating results.this Form 10-Q.

To date, twelve putative class action antitrust lawsuits have been filed against us along with co-defendants, including Taro Pharmaceuticals U.S.A., Inc. and Perrigo New York Inc. One “opt-out” action has additionally been filed against us along with thirty five generic manufacturer co-defendants regarding the pricing of econazole nitrate cream and twenty nine additional drug products not manufactured or sold by us. All actions have been transferred by the Judicial Panel on Multidistrict Litigation to the Eastern District of Pennsylvania for pre-trial proceedings as part of the In re Generic Pharmaceuticals Pricing Antitrust Litigation matter, and the class actions have been consolidated into direct purchaser, end payer and indirect reseller actions.

The class plaintiffs seek to represent nationwide or state classes consisting of persons who directly purchased, indirectly purchased, paid, and/or reimbursed patients for the purchase of generic econazole from July 1, 2014 until the time the defendants’ allegedly unlawful conduct ceased or will cease.

The opt-out plaintiffs allege a conspiracy by thirty-six generic manufacturers to fix prices for thirty drug products including


econazole nitrate cream, in violation of federal antitrust laws. The opt-out plaintiffs seek treble damages for alleged price overcharges for the thirty drug products identified in the complaint during the alleged period of conspiracy, and also seek injunctive relief against the defendants.

All of these cases are in their initial stages and motions to dismiss have been filed with respect to each of the complaints. Due to the early stage of these cases, we are unable to form a judgment at this time as to whether an unfavorable outcome is either probable or remote or to provide an estimate of the amount or range of potential loss. We believe these cases are without merit, and we intend to vigorously defend against these claims.

On October 20, 2017, a Demand for Arbitration was filed with the American Arbitration Association by Stayma Consulting Services, Inc. (“Stayma”) against us regarding our development and manufacture for Stayma of two generic drug products, one a lotion and one a cream, containing 0.05% of the active pharmaceutical ingredient flurandrenolide. We developed the two products and Stayma purchased commercial quantities of each; however, Stayma now alleges that we breached agreements between the parties by developing an additional and different generic drug product, an ointment, containing flurandrenolide, and failing to meet certain contractual requirements. Stayma seeks monetary damages. Because discovery in this matter is ongoing, we are unable to form a judgment at this time as to whether an unfavorable outcome is either probable or remote or to provide an estimate of the amount or range of potential loss. We believe this case is without merit, and we intend to vigorously defend against these claims. We filed a counter-claim against Stayma for its failure to pay several past due invoices of approximately $1.7 million relating to the development and commercial supply of the two subject products. These invoices have been fully reserved.
ITEM 1A. Risk Factors
 
Part I, Item 1A, “Risk Factors,” of our Annual Report on Form 10-K for the year ended December 31, 20172018 includes a detailed discussion of risks and uncertainties which could adversely affect our future results. Except as set forth below, the risks described in our Annual Report on Form 10-K for the year ended December 31, 20172018 have not materially changed.
 
Risks Related to Our Business 

We have a history of losses and cannot assure you that we will become profitable, and as a result, we may have to cease operations and liquidate our business.
With the exception of 2015 and the three month period ended March 31, 2017, our expenses have exceeded our revenue in each of the last 12 years, and no net income has been available to common stockholders during each of these years. As of June 30, 2018, our stockholders’ equity was $38.7 million and we had an accumulated deficit of $78.0 million. Our future profitability depends on revenue exceeding expenses, but we cannot assure you that this will occur. If we do not become profitable or continue to raise external financing, we could be forced to curtail operations and sell or liquidate our business, and you could lose some or all of your investment.

We rely on a limited number of customers for a large portion of our revenues.
We depend on a limited number of customers for a large portion of our revenue. Three of our customers accounted for 49% of our revenue for the three months ended June 30, 2018, and three of our customers accounted for 50% of our revenue for the three months ended June 30, 2017. For the six months ended June 30, 2018, two of our customers accounted for 48% of our revenue and for the six months ended June 30, 2017, three of our customers accounted for 52% of our revenue. The loss of one or more of these customers could have a significant adverse impact on our revenues and harm our business and results of operations.

Due to concentration of sales in a limited number of products, our business will be materially adversely affected if these products do not perform as well as expected.

We expect to generate a significant portion of our total revenues and gross margin from the sale of a limited number of products. While we continue to diversify our product portfolio, two of our products accounted for 13% of our revenue for the three months ended June 30, 2018. Any material adverse developments, including increased competition, loss of customers, pricing pressures and supply shortages, with respect to the sale or use of our products and prospective products, or our failure to successfully introduce such products, could have a material adverse effect on our revenues and gross margin.

If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results, and current and potential stockholders may lose confidence in our financial reporting.



We are required by the SEC to establish and maintain adequate internal control over financial reporting that provides reasonable assurance regarding the reliability of our financial reporting and the preparation of financial statements in accordance with generally accepted accounting principles. We are likewise required, on a quarterly basis, to evaluate the effectiveness of our internal controls and to disclose any changes and material weaknesses in those internal controls.

As disclosed elsewhere herein, in connection with our financial review management concluded that a material weakness related to the Company not having adequate personnel and resources in place for its implementation of a new ERP existed, and consequently, the same financial reporting personnel were not able to perform a timely and effective review of our period-end closing process.

As the Company continues to expand, it will require a level of technical expertise for certain complex accounting transactions.  The Company restated its second quarter ending June 30, 2018, due to an error in the accounting related to the debt extinguishment. 
While the Company needed to restate the quarter ending June 30, 2018, there was no change in the Company’s internal control over financial reporting during the Company’s second quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.  Accounting errors corrected in the quarter were systemic to the material weaknesses previously identified by the Company.

Since the determination regarding this material weakness, we have devoted, and will continue to devote, significant effort and resources to the remediation and improvement of our internal control over financial reporting. Our plans include the following: new internal and external personnel, new business process improvements and a review of relevant training. The elements of our remediation plan can only be accomplished over time and we can offer no assurance that these initiatives will ultimately have the intended effects. Any failure to maintain such internal controls or effectively implement our remediation plan could adversely impact our ability to report our financial results on a timely and accurate basis. If our financial statements are not accurate, investors may not have a complete understanding of our operations, which may have a material adverse effect on our business.

We are subject to stringent regulatory requirements. Failure to adhere to such requirements could harm our business, financial condition and results of operations. 

In the United States, we and our suppliers of raw materials are subject to regulation under the Occupational Safety and Health Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act and other current and potential future federal, state or local regulations. Failure to adhere to such regulations, by either us or our suppliers, could harm our business, financial condition and results of operations. In addition, our analytical department uses certain hazardous materials and chemicals in limited and controlled quantities. We have implemented safety procedures for handling and disposing of such materials, however, such procedures may not comply with the standards prescribed by federal, state and local regulations. Even if we follow such safety procedures for handling and disposing of hazardous materials and chemicals and such procedures comply with applicable law, the risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of such an accident, we could be held liable for any damages and any such liability could exceed our resources. 

Our operations and properties are also subject to a wide variety of increasingly complex and stringent federal, state and local environmental laws and regulations, including those governing the remediation of contaminated soil and groundwater. Such environmental laws may apply to conditions at properties and facilities presently or formerly owned or operated by us, as well as to conditions at properties at which wastes or other contamination attributable to us have been sent or otherwise come to be located. One of our facilities has undergone remediation of environmental contamination, and one of our facilities is currently undergoing remediation of environmental contamination. The total estimated costs for the clean-up and remediation is $0.9 million as of June 30, 2018, and remaining costs accrued at June 30, 2018 totaled $0.1 million. Based on information provided to us from our environmental consultants and what is known to date, we believe the reserves are sufficient for the remaining remediation of the environmental contamination. There is a possibility, however, that the remediation costs may exceed our estimates. In addition, we can give no assurance that the future cost of compliance with existing environmental laws will not give rise to additional significant expenditures or liabilities that would be material to us. Future events, such as new information, changes in existing environmental laws or their interpretation, and more vigorous enforcement policies of federal, state or local regulatory agencies, may have a material adverse effect on our business, financial condition and results of operations. 

In Canada, we and our suppliers of raw materials are also subject to regulation under Hazardous Products Act, Controlled Products Regulations, Consumer Product Safety Act, Canadian Environmental Protection Act and other current and potential future federal, provincial/territorial or local regulations. Failure to adhere to such regulations, by either us or our suppliers, could harm our business and results of operations. In addition, our analytical department uses certain hazardous materials and chemicals in limited and controlled quantities. We have implemented safety procedures for handling and disposing of such materials, however, such procedures may not comply with the standards prescribed by federal, provincial/territorial and local regulations. Even if we follow such safety procedures for handling and disposing of hazardous materials and chemicals and such procedures comply with


applicable law, the risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of such an accident, we could be held liable for any damages and any such liability could exceed our resources. 

Future events, such as new information, changes in existing environmental laws or their interpretation, and more vigorous enforcement policies of federal, provincial/territorial or local regulatory agencies, may have a material adverse effect on our business, financial condition and results of operations.
Significant balances of intangible assets, including goodwill, are subject to impairment testing and may result in impairment charges, which may materially and adversely affect our results of operations and financial condition. 

A significant amount of our total assets is related to goodwill and intangible assets. As of June 30, 2018, the value of our goodwill and intangible assets net of accumulated amortization was $53.4 million. Goodwill and other intangible assets are tested for impairment annually when events occur or circumstances change that could potentially reduce the fair value of the reporting unit or intangible asset. Impairment testing compares the fair value of the reporting unit or intangible asset to its carrying amount. Any future goodwill or other intangible asset impairment, if any, would be recorded in operating income and could have a material adverse effect on our results of operations and financial condition.

Our ability to use our net operating loss carry forwards and certain other tax attributes may be limited. 

As of December 31, 2017, we had U.S. federal net operating losses (NOLs) of approximately $41.7 million which will expire from 2020 through 2037. The use of these NOLs may be limited in future years under IRC Section 382 which imposes an annual limitation on the amount of taxable income that can be offset by NOL carryovers and certain built in losses (collectively referred to as Pre-change Losses) that are attributable to the period preceding an ownership change. Under Code Section 382, an ownership change occurs when one or more “Five-percent Shareholders” increase their ownership in the corporation’s stock, in the aggregate, by more than fifty percentage points during a three-year testing period. An ownership change as defined by Code Section 382 occurred during 2010 and triggered a limitation under Code Section 382 on the usage of an aggregated $23.3 million of NOLs at the change date. We estimate that the annual limitation on such NOLs aggregates from $1.0 million to $2.3 million per year including the effect of amortization of built in gains. NOL's since the 2010 change date aggregate $23.1 million and we do not believe that these NOLs are subject to limitation. Limitation NOLs utilized aggregated $4.7 million as of December 31, 2017.

Currency fluctuations and changes in exchange rates could adversely affect our business, financial condition, results of operations, cash flows, and/or common stock price.
Although we report our financial results in U.S. Dollars, a portion of our revenues and other liabilities and our costs are denominated in non-U.S. currencies, including the Euro and Canadian Dollar. Our results of operations and, in some cases, cash flows, have in the past been and may in the future be adversely affected by certain movements in currency exchange rates. The occurrence of any of the above risks could cause a material adverse effect on our business, financial condition, results of operations, cash flows, and/or share price.

The Company is exposed to market risk from fluctuations in currency exchange rates.

The Company operates in multiple jurisdictions denominated in currencies of the local jurisdiction. Additionally, the Company
may enter into acquisition, licensing, borrowing or other financial transactions that may give rise to currency exposure. Since
the Company cannot, with certainty, foresee and mitigate against such adverse fluctuations, fluctuations in currency exchange
rates could negatively affect the Company’s results of operations, financial position and cash flows.

We have identified material weaknesses in our internal control over financial reporting, and if we are unable to satisfy regulatory requirements relating to internal controls, our stock price could suffer.
Section 404 of the Sarbanes-Oxley Act of 2002 requires companies to conduct a comprehensive evaluation of the effectiveness of their internal control over financial reporting. At the end of each fiscal year, we must perform an evaluation of our internal control over financial reporting, include in our annual report the results of the evaluation and have our external auditors also publicly attest to the effectiveness of our internal control over financial reporting. We have identified material weaknesses in our internal control over financial reporting, and if additional material weaknesses are found in our internal controls in the future, if we fail to remediate our existing material weaknesses, if we fail to complete future evaluations on time or if our external auditors cannot attest to the effectiveness of our internal control over financial reporting, we could fail to meet our regulatory reporting requirements and be subject to regulatory scrutiny and a loss of public confidence in our internal controls, which could have an adverse effect on our stock price.



We have identified material weaknesses in our internal control over financial reporting, which could continue to impact negatively our ability to report our results of operations and financial condition accurately and in a timely manner.
As required by Section 404 of the Sarbanes-Oxley Act of 2002, management has conducted an evaluation of the effectiveness of our internal control over financial reporting at June 30, 2018. We identified a number of material weaknesses in our internal control over financial reporting and concluded that, as of June 30, 2018, we did not maintain effective control over financial reporting based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. For a detailed description of these material weaknesses, see Item 4, "Controls and Procedures." Each of our material weaknesses results in more than a remote likelihood that a material misstatement of the annual or interim financial statements that we prepare will not be prevented or detected. As a result, we must perform extensive additional work to obtain reasonable assurance regarding the reliability of our financial statements. Moreover, other material weaknesses may be identified.

We are in the process of remedying all of the identified material weaknesses, and this work will continue during fiscal 2018 and beyond. For a detailed description of our remedial efforts, see Item 4, "Controls and Procedures." There can be no assurance as to when all of the material weaknesses will be remedied, if at all. Until our remedial efforts are completed, management will continue to devote significant time and attention to these efforts, and we will continue to incur expenses associated with the additional procedures and resources required to prepare our Consolidated Financial Statements. Certain of our remedial actions, such as hiring additional qualified personnel to implement our reconciliation and review procedures, will be ongoing and will result in our incurring additional costs even after our material weaknesses are remedied.
If we are unsuccessful in implementing or following our remediation plan, or fail to update our internal control over financial reporting as our business evolves or to integrate acquired businesses into our controls system, if additional material weaknesses are found in our internal controls in the future, or if our external auditors cannot attest to the effectiveness of our internal control over financial reporting, we may not be able to timely or accurately report our financial condition, results of operations or cash flows or to maintain effective disclosure controls and procedures. If we are unable to report financial information in a timely and accurate manner or to maintain effective disclosure controls and procedures, we could be subject to, among other things, regulatory or enforcement actions by the SEC, an inability for us to be accepted for listing on any national securities exchange in the near future, securities litigation and a general loss of investor confidence, any one of which could adversely affect our business prospects and the market value of our Common Stock. Further, there are inherent limitations to the effectiveness of any system of controls and procedures, including the possibility of human error and the circumvention or overriding of the controls and procedures. We could face additional litigation exposure and a greater likelihood of an SEC enforcement or other regulatory action if further restatements were to occur or other accounting-related problems emerge. In addition, any future restatements or other accounting-related problems may adversely affect our financial condition, results of operations and cash flows.

Risks Related to our Indebtedness
Our substantial indebtedness could materially adversely affect our business, financial condition or results of operations and prevent us from fulfilling our obligations under the Notes.
As of June 30, 2018, our total consolidated net indebtedness was $129.9 million. Our substantial level of indebtedness coupled with our net loss increases the possibility that we may be unable to generate cash sufficient to pay, when due, the principal of, interest on, or other amounts due in respect of our indebtedness. Our substantial indebtedness, combined with our other financial obligations and contractual commitments, may have a material adverse impact on us. For example, it could

make it difficult for us to satisfy our obligations with respect to our outstanding and other future debt obligations;
increase our vulnerability to general adverse economic conditions or a downturn in the industries in which we operate;
impair our ability to obtain additional financing in the future for working capital, investments, acquisitions and other general corporate purposes;
require us to dedicate a substantial portion of our cash flows to the payment to our financing sources, thereby reducing the availability of our cash flows to fund working capital, investments, acquisitions and other general corporate purposes; and
place us at a disadvantage compared to our competitors.

Risks Related to Our Securities
Shares of our common stock are relatively illiquid which may affect the trading price of our common stock.
For the six months ended June 30, 2018, the average daily trading volume of our common stock on the NASDAQ Global Select Market was approximately 693,254 shares. As a result of our relatively small public float, our common stock may be less liquid


than the stock of companies with broader public ownership. Among other things, trading of a relatively small volume of our common stock may have a greater impact on the trading price for our shares than would be the case if our public float were larger.

ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds
 
39

None.
 
ITEM 3. Defaults Upon Senior Securities
 
None.
 
ITEM 4. Mine Safety Disclosures


None. 



ITEM 5. Other Information

None.






40

ITEM 6. Exhibits


Exhibit NumberDescription
Exhibit Number31.1*Description
31.1*
31.2*
32.1*
32.2*
33.1*
Separation Agreement
10.1*101*
The Company is filing a corrected copy of its Amended and Restated 2016 Equity Incentive Plan (the “2016 Plan”) as Exhibit [10.1] hereto, in the interest of correcting a typographical error that appeared in the previous filing of the 2016 Plan.  No other changes have been made to the 2016 Plan.”
101*The following financial information from this Quarterly Report on Form 10-Q for the period ended June 30, 2018,March 31, 2019, formatted in XBRL (Extensible Business Reporting Language): (i) the Condensed Consolidated Statements of Operations; (ii) the Condensed Consolidated Balance Sheets; (iii) the Condensed Consolidated Statements of Cash Flows; (iv) the Condensed Consolidated Statement of Comprehensive Income(Loss); (v) the Condensed Consolidated Statement of Equity; and (vi) the Notes to Condensed Consolidated Financial Statements, tagged as blocks of text.
 
* Filed herewith.


41

SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 
Teligent, Inc.
Date: May 10, 2019Teligent, Inc.
By:
Date: December 12, 2018By:/s/   Jason Grenfell-Gardner
Jason Grenfell-Gardner
President and Chief Executive Officer
Date: December 12, 2018May 10, 2019By:/s/   Damian Finio
Damian Finio
Chief Financial Officer
 
Exhibit Index
 
Exhibit NumberDescription
Exhibit Number31.1*Description
31.1*
31.2*
32.1*
32.2*
33.1*
Separation Agreement
10.1*
The Company is filing a corrected copy of its Amended and Restated 2016 Equity Incentive Plan (the “2016 Plan”) as Exhibit [10.1] hereto, in the interest of correcting a typographical error that appeared in the previous filing of the 2016 Plan.  No other changes have been made to the 2016 Plan.”
101*
The following financial information from this Quarterly Report on Form 10-Q for the period ended June 30, 2018,March 31, 2019, formatted in XBRL (Extensible Business Reporting Language): (i) the Condensed Consolidated Statements of Operations; (ii) the Condensed Consolidated Balance Sheets; (iii) the Condensed Consolidated Statements of Cash Flows; (iv) the Condensed Consolidated Statement of Comprehensive Income(Loss); (v) the Condensed Consolidated Statement of Equity; and (vi) the Notes to Condensed Consolidated Financial Statements, tagged as blocks of text.
 
* Filed herewith.



51
42